Systems and methods for sternum repair

ABSTRACT

The invention provides systems and methods for sternum repair. A sternum repair device may include a central body, which may include a plurality of bands and buckles, such that a band extends from the central body and is received by a buckle component. The band may wrap around the sternum and the device may be tightened to keep the separate sternum pieces together.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 12/888,357 filed on Sep. 22, 2010, which issued as U.S. Pat. No.8,460,295, which is a continuation-in-part of pending U.S. applicationSer. No. 12/727,212 filed on Mar. 18, 2010, which claims the benefit ofU.S. Provisional Application No. 61/161,515 filed Mar. 19, 2009 and U.S.Provisional Application No. 61/252,145 filed Oct. 15, 2009, whichapplications are incorporated herein by reference in their entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to tissue closure. More specifically, thedisclosure relates to devices, systems and methods of connecting andclosing portions of a sternum after a partial or full sternotomy.

BACKGROUND OF THE INVENTION

Conventional methods for sternum repair following surgery often involveextensive forces being applied, which may be difficult to apply anduncomfortable. For example, sternal repair following heart surgerytypically uses steel wire which is passed between the ribs andtwisted/crimped together to achieve stability between the bone edges.

For sternal reconstruction the wires are subject to stress forces causedby sternal movement from breathing. This leads to metal fatigue andfracturing. Wire integrity loss can cause sternal infection andnon-union. This occurs in 5% of all open heart surgeries. Furthermorethere have been reports of allergy to metals which often prompts theremoval of wires and risk exposure by the patient. The wires are alsodependent upon the skill of the surgeons as they tighten the wires. Toomany turns in the wire may unnecessarily weaken the wire and subject itto future failure. Sternal plating systems have been developed, muchlike plates for fractured bones; however there are many hurtles in thesuccess of the plates. They are cumbersome and difficult to apply, andthe cardiothoracic surgeons are usually not trained or comfortable withthe application. Typically, they are reserved for sternal dehiscencecases, and they are expensive.

Accordingly, there exists a need for improved systems and methods forsternum repair.

SUMMARY OF THE INVENTION

The invention provides systems and methods for sternum repair. Variousaspects of the invention described herein may be applied to any of theparticular applications set forth below or for any other types of tissueconnection. The invention may be applied as a standalone system ormethod, or as part of integrated medical procedure, such as cardiacsurgery. It shall be understood that different aspects of the inventioncan be appreciated individually, collectively, or in combination witheach other.

One aspect of the invention is directed to a sternum connecting device.The sternum connecting device may include a central body. The centralbody may include a plurality of male stems, a plurality of male basesconnected to the male stems, a plurality of female stems, and aplurality of female bases connected to the female stems. The sternumconnecting device may also include a plurality of male sutures, whereina male suture extends from a male base and is configured to be revisedfemale base, wherein at least one of the male stems or female stems isoriented at a non-parallel angle to another male stem or female stem.

In accordance with another embodiment of the invention, a connectiondevice may be provided comprising a central body. The central body mayinclude a plurality of male stems, a plurality of male bases connectedto the male stems where a male base is configured to serve as a takingoff point of a male suture, a plurality of female stems, and a pluralityof female bases connected to the female stems where a female base isconfigured to accept the male suture taking off from the male base. Insome instances, at least one of the male or female bases may beconfigured to enable the male suture to change orientation at the maleor female base with respect to the male or female stem to which the maleor female base is connected.

A method for connecting two tissues may be provided in accordance withanother aspect of the invention. The method may include a step ofproviding a connection device, which may include a central body with aplurality of male stems, a plurality of female stems, and a plurality offemale bases connected to the female stems. The connection device mayalso include a plurality of male sutures, wherein a male suture may beconnected to and extend from a male stem. The method may also includethe steps of wrapping a first male suture around the two tissues andconnecting the first male suture to a first female base, and wrapping asecond male suture around the two tissues and connecting the second malesuture to a second female base.

Other goals and advantages of the invention will be further appreciatedand understood when considered in conjunction with the followingdescription and accompanying drawings. While the following descriptionmay contain specific details describing particular embodiments of theinvention, this should not be construed as limitations to the scope ofthe invention but rather as an exemplification of preferableembodiments. For each aspect of the invention, many variations arepossible as suggested herein that are known to those of ordinary skillin the art. A variety of changes and modifications can be made withinthe scope of the invention without departing from the spirit thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 shows a sternal device in accordance with an embodiment of theinvention.

FIG. 2 shows another configuration for a sternal device.

FIG. 3A shows an upper perspective view of another embodiment of asternal device.

FIG. 3B shows a side view of another embodiment of a sternal device.

FIG. 3C shows a bottom view of another embodiment of a sternal device.

FIG. 3D shows a lower perspective view of another embodiment of asternal device.

FIG. 4A shows a sternum connecting device in accordance with anembodiment of the invention.

FIG. 4B shows a sternum connecting device after a needle is drawnthrough a female base.

FIG. 4C shows a sternum connecting device as a male suture is drawnthrough a female base.

FIG. 5 shows an example of a central body shape.

FIG. 6 shows another example of a central body shape.

FIG. 7A shows a central body with elongated stems.

FIG. 7B shows a central body with multiple layers.

FIG. 7C shows a central body with shorter stems.

FIG. 8 shows a contoured central body of a sternal device.

FIG. 9 shows a central body of a sternal device with holes.

FIG. 10 shows a central body of a sternal device with an irregulartextured surface.

FIG. 11 shows an artificial hip joint with an irregular texturedsurface.

FIG. 12 shows a relationship between tension and freedom of wiggle for asternal device joint.

FIG. 13 illustrates a suture connected to a body.

FIG. 14 shows a sternal device body with male and female bases.

FIG. 15 shows a male suture with a ball and socket joint.

FIG. 16 shows a male suture connected to a male base of a sternaldevice.

FIG. 17 shows a female base of a sternal device in accordance with anembodiment of the invention.

FIG. 18 shows a range of rotation for a female base.

FIG. 19A shows a female base on a female stem, which may move along arestrictive path relative to the stem.

FIG. 19B shows a side view of a female base on a female stem.

FIG. 20 provides views of additional examples of female bases and stems.

FIG. 21 shows an example of a tool that may be used to tighten a malesuture along a female base.

FIG. 22 shows examples of various possible suture configurations.

FIG. 23 provides an additional example of a suture configuration.

FIG. 24 shows an example of forces at play on a split sternum.

FIG. 25 provides an example of a sternum connecting device disposed on asplit sternum.

FIG. 26 shows an example of a sternal device with flexible componentsthat can be disposed in a body.

FIG. 27 provides a view from a bottom of a body to view a profile of asternal device.

FIG. 28 shows a sternal device on a sternum in accordance with anotherembodiment of the invention.

FIG. 29A shows an example of a sternal device spanning one set of ribs.

FIG. 29B shows an example of a sternal device spanning two sets of ribs.

FIG. 30 shows an example of a sternal device spanning two ribs on asternum.

FIG. 31A shows a step for applying a sternal device in a body.

FIG. 31B shows another step for applying a sternal device in a body.

FIG. 32A illustrates a step for providing a sternum connecting device ona sternum.

FIG. 32B illustrates an additional step to place a sternum connectingdevice on a sternum.

FIG. 32C illustrates how a sternum connecting device may be used toconnect a sternum.

FIG. 32D illustrates a subsequent step for connecting a sternum using asternum connecting device.

FIG. 33 shows a tensioning gun that may be used to tighten a sternumconnecting device.

FIG. 34 shows how a tensioning gun may be used to tighten a sternumconnecting device.

FIG. 35 shows a linking bar provided in accordance with an embodiment ofthe invention.

FIGS. 36A-36E show various embodiments of tissue closure devices.

FIG. 36F shows an offset feature that may be used with any of the tissueclosure devices.

FIG. 37 shows two different tissue closure devices used to closeportions of a sternum after a full sternotomy.

FIG. 38 shows a tissue closure device used to close portions of asternum after a partial sternotomy.

FIG. 39 shows a tissue closure device used to close portions of asternum after a partial sternotomy.

FIGS. 40-44 show various embodiments of tissue closure devices havingbands pivotably connected at mid-portions.

FIGS. 45-48 show various embodiments of tissue closure devices havingbands pivotably connected at end-portions.

FIGS. 49A-49C show an exemplary eyelet that may be used to pivotablyconnect modular components of tissue closure devices.

FIGS. 50A-50C show various embodiments of an H-shaped tissue closuredevice.

FIGS. 51-55 show additional features that may be incorporated into anyof the closure devices disclosed herein.

FIG. 56 shows another embodiment of an H-shaped tissue closure device.

FIGS. 57A-57B show another embodiment of a tissue closure device.

FIGS. 58A-58C, 59A-59D, 60A-60B, 61A-61B, 62A-62B, 63, 64A-64D, 65A-65H,and 66A-66C show various alternatives for forming buckles and otherlocking mechanisms, and for securing bands of tissue closure deviceswith the locking mechanisms.

FIGS. 67A-67C, 68A-68C, 69A-69B, 70A-70D, 71A-71B, 72A-72C, 73A-73C,74A-74C, 75A-75C, 76A-76C show further details of needle configurationsthat may be used with any of the tissue closure devices disclosedherein.

DETAILED DESCRIPTION OF THE INVENTION

While preferred embodiments of the invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention.

Sternal Device

FIG. 1 shows a sternal device in accordance with an embodiment of theinvention. A sternal device may include a central body 100 which mayinclude one, two, or more male stems 102 and one, two, or more femalestems 104. Preferably, the central body has a plurality of male stemsand a plurality of female stems. A central body may also optionallyinclude one, two, or more male bases 106 and one, two, or more femalebases 108.

Any number of male stems, female stems, and/or corresponding bases maybe provided. Preferably, the same number of male and female stems may beprovided. For instance, if two male stems are provided, two female stemsare provided. Alternatively, there may be different number of male andfemale stems. In some examples, one, two, three, four, five, six, seven,eight, or more male stems, female stems, and/or corresponding bases maybe provided (e.g., two male stems and one female stem).

The male and/or female stems may be integral to the central body.Alternatively, they may be separable from the central body. This will bediscussed in further detail below.

A male base may be connected to a male stem, and female base may beconnected to a female stem. In preferable embodiments, each male basemay be connected to a male stem, and each female base may be connectedto a female stem. Alternatively, a plurality of male bases may beconnected to a male stem and/or a plurality of female bases may beconnected to a female stem. In other embodiments, a plurality of malestems may be connected to a male base and/or a plurality of female stemsmay be connected to a female base. In some embodiments, a male stem doesnot have a male base, or a female stem does not have a female base.

In some embodiments, a male stem and/or female stem may have anelongated shape. The degree of elongation may vary (e.g., male and/orfemale stems may be long and thin, or more short and stubby). Maleand/or female stems may extend from a common central region of thecentral body. At least one male stem or female stem may be oriented at anon-parallel angle to another male stem or female stem. In someinstances, all male stems may form non-parallel angles with respect toother male stems and/or all female stems may form non-parallel angleswith respect to other female stems. The male and/or female stems may allintersect from the common central region of the central body.Alternatively, some male and/or female stems may intersect at or near acommon central region of the central body. In some instances, the maleand female stems may form a cross-shape or X-shape. Alternatively, theymay form a shape similar to spokes on a wheel, extending from a commoncentral region.

A sternal device may also include one or more male sutures 110. A malesuture may extend from a male base. The male stem may be integral orseparable from the male base. Alternatively, a male suture may beintegral or separable from a male stem and extend from the male stem.Preferably, each male base may be connected to a male suture. Preferablya one-to-one correspondence may exist between a male stem and a malesuture. Alternatively, male stem may be directly or indirectly connectedto zero, one, two, or more male sutures. Or a male suture may bedirectly or indirectly connected to one, two, or more male stems.

A male suture 110 may be configured to be received by a female base 108.Preferably, each male suture may be configured to be received by adifferent female base. Each male stem may have a corresponding femalestem, which may be connected via a male suture. Alternatively, a femalebase may be configured to receive a plurality of male sutures. In someembodiments, a female base may receive a male suture so that the malesuture may only travel in one direction with respect to the female base.For example, a male suture may pass through the female base in only onedirection. This may result in tightening the sternal device withoutallowing it to be loosened. Alternatively, a tightening mechanism may beprovided on the female base. For example, a male suture may be allowedto slide in either direction through a female base until the tighteningmechanism is engaged, and the male suture is fixed in place, or onlyallowed to slide in one direction with respect to the female base.

The bases may serve as the “take off” and “receptacle” of a male suture.The male base may be where the security of the male-female interactionis.

In some instances, a male suture 110 may have an engagement zone 112. Amale suture may have a first end and an opposing second end. The firstend of the male suture may be at a male base or male stem from which themale suture extends. The engagement zone may be at the second end of themale suture. The engagement zone may narrow the male suture. Forexample, if a male suture has a diameter D1 along its length, at theengagement zone, the diameter of the male suture may decrease to D2,where D2 is less than D1. The diameter decrease may occur gradually orsuddenly. Similarly, if a male suture has a width W1 along its length,at the engagement zone, the width of the male suture may decrease to W2,where W2 is less than W1. The width decrease may occur gradually orsuddenly. In some instances, an engagement zone may have a conical ortapered shape. The engagement zone may be a cone-like dilator or can bea standard suture.

A male suture 110 may optionally be connected to a delivery needle 114.The delivery needle may or may not be directly connected to anengagement zone 112 of a male suture. In some instances, the deliveryneedle may be indirectly connected to an engagement zone of the malesuture via a line or thread. Alternatively, the delivery needle may bedirectly or indirectly connected to the male suture without goingthrough an engagement zone. In some instances, the delivery needle maybe separable from the male suture or may be integral to the male suture.In some instances, an engagement zone of the male suture may be formedof a pointed and rigid material that may be used as a delivery needle.The delivery needle may be substantially straight or may be curved. Thedelivery needle may be any needle known or later developed in the artwhich may allow the delivery of the sternal device around the sternum.

A sternal device may be delivered around a sternum or other similaranatomical features to connect pieces of the sternum. A sternal/ribhorizon may be where the sternum and rib may meet. There may be softtissue above and below where a male suture may pass through. Applicationof a sternal device within a subject will be discussed in further detailbelow.

In some embodiments, a male suture is configured to be accepted by afemale base that is not adjacent to the male base from which it extends.For example, if a sternal device has a pair of female stems withcorresponding female bases, and a pair of male stems with correspondingmale bases, a first male suture from a first male base may be acceptedby a first female base, where the first male base and first female baseare on stems that are not adjacent to one another, but rather areopposite one another. Similarly, a second male suture from a second malebase may be accepted by a second female base, where the second male baseand second female base are on stems that are not adjacent to oneanother, but rather are opposite one another. In such situations, thefirst male suture may be configured to cross the second male suture whenthe first and second male sutures are received by their respectivefemale base. Thus a first male suture may cross over a second malesuture, or vice versa, when they are accepted by their respective femalebases. Thus, a first male suture may contact and/or intersect a secondmale suture

FIG. 2 shows another configuration for a sternal device. The sternaldevice may have a main body 200. The main body may have a plurality ofelongated stems. For example, two male stems 202 a, 202 b and two femalestems 204 a, 204 b may be provided. In some instances, the male and/orfemale stems may be long and narrow. A female stem may be connected to afemale locking zone 206. The female stem may be the base 214 of thefemale suture. The female locking zone may be configured to accept amale suture 208.

In some embodiments, the main body, female stem, and/or male stems maybe made of a rigid, semi-rigid, or flexible material. A male suture maypreferably be made of a flexible material, although alternatively it maybe made of a semi-rigid or rigid material. Any of the components may bemade from the same or different materials with various materialproperties. Any of the materials may or may not extend, stretch, bend,fold, or retain shape.

A male suture 208 may extend from a male stem 202 a. In some instances,the male suture may be integral to the male stem. The male stem may bethe base 210 of the male suture. The male suture may be narrower thanthe male stem. Alternatively, the male suture may have a similarcross-sectional size to the male stem. The male suture may graduallydecrease in cross-sectional area as it extends from the male stem.Alternatively, it may retain the same cross-sectional area. In someinstances, the male suture may be more flexible than the male stem.

A male suture 208 may include a male locking zone 212. The male lockingzone may include locking features that may be accepted by a female base214, but may prevent the male suture from sliding in at least onedirection with respect to the female locking zone 206. For example, themale suture may pass in one way through the female base to tighten thesternal device, but may be prevented from passing in the oppositedirection through the female locking zone. The male locking zone may beprovided along the entire length of the male suture. Alternatively, itmay be along one or more portions of the male suture. The locking zonemay be closer to the end of the suture adjacent to the male stem, or maybe closer to the end of the suture that is received by the femalelocking zone.

The locking features provided on a male locking zone may include anysuture morphology or structure that may assist with causing the malesuture to lock within the female locking zone, to prevent the malesuture from moving in at least one direction. The locking zones mayinclude ball shapes, cone shapes, bumps, teeth, jagged edges, holes, orgrooves.

The male suture 208 may have an engagement zone 216. The engagement zonemay narrow the male suture. The engagement zone may have orientationfeatures. An engagement zone may assist with guiding a male suturethrough a female locking zone. In some embodiments, the engagement zonemay be adjacent to a locking zone. Alternatively, the engagement zonemay be adjacent to a region of the male suture that is not the malelocking zone.

The male suture 208 may optionally be connected to a delivery needle218. The delivery needle may or may not be directly connected to anengagement zone 216 of a male suture. The delivery needle may be anyneedle known or later developed in the art which may allow the deliveryof the sternal device around the sternum.

The sternal device may be configured to wrap around a sternum. Across-section of a sternum may be illustrated 220. A main body may bedisposed along a first side of a sternum, while the male sutures maywrap around the opposing side of the sternum. A male suture may engagewith the female locking zone, so that the male locking zone contacts thefemale locking zone. The sternum may be encircled by the sternal device.

FIG. 3A shows an upper perspective view of another embodiment of asternal device. The sternal device may include two male stems 300 a, 300b connected to male sutures 302 a, 302 b and two female stems 304 a, 304b connected to two female locking zones 306 a, 306 b. The male stems andthe female stems may be oriented within the main body 308 so that themale stems are not parallel to one another and the female stems are notparallel to one another. The male and female stems may be oriented toform a cross-shape.

Male sutures may be integrally connected to the male stems. The malesutures may be provided of a flexible, semi-rigid, or rigid material. Insome instances, a male suture 302 a may engage with a female stem 304 athat is adjacent to the corresponding male stem 300 a of the malesuture. In such situations, when the male sutures engage with theircorresponding female locking zones, the male sutures may besubstantially parallel to one another. The male sutures are notintersecting one another. In other instances, a male suture 302 a mayengage with a female stem 304 b that is not adjacent to thecorresponding male stem 300 a of the male suture, but is opposite thecorresponding male stem. In such situations, when the male suturesengage with their corresponding female locking zones, the male suturesmay be substantially non-parallel to one another. The male sutures areintersecting one another, and may form a cross-shape.

The central portion of the main body may be substantially flat and mayfit over a first side (front) of a sternum. The male and/or female stemsmay be contoured to wrap around a sternum so that they hang over thesides of the sternum. Thus, a male suture may engage with a femalelocking zone over a side of a sternum rather than over the front side ofa sternum. Similarly, a male suture may connect to a male stem over aside of the sternum rather than over the front side of the sternum.

In alternate embodiments, the length and/or contour of the male andfemale stems may vary. Thus, in some alternate embodiments the malesuture and female locking zone may interface along the front side of thesternum adjacent to the central part of the main body, or along the backside of the sternum, or anywhere along the circumference of the sternum.

FIG. 3B shows a side view of another embodiment of a sternal device. Theprofile of the sternal may be thin, so that there aren't significantbumps or protrusions from the sternal device when it is used within asubject. For example, the central part of the main body 310, the stemsof the main body 312 a, 312 b, the male sutures 314, the female lockingzones 316, and/or any other components may have a very low profile, andmay be shaped to fit a sternum (or other comparable anatomical region)of the subject.

In some embodiments, the components of the sternal device may be 1 cm orless in profile, or may be about 0.5 cm or less, 0.3 cm or less, 0.2 cmor less, 0.1 cm or less, 0.07 cm or less, 0.05 cm or less, 0.02 cm orless, 0.01 cm or less, 0.007 cm or less, 0.005 cm or less, 0.002 cm orless, 0.001 cm or less. The contours of the sternal device may also besmooth so that no rough or sharp edges are protruding from the sternaldevice. This may help prevent the sternal device from causing irritationor getting caught on tissues within the region.

In some embodiments, the interface where a male suture extends from amale stem may be smooth. The male suture may be integrally connected tothe male stem. Alternatively, the male suture may be separable from themale stem and/or may be connected via a male base. The profile where themale base connects to the male stem and/or base may still be very thinand/or smoothly contoured.

FIG. 3C shows a bottom view of another embodiment of a sternal device.The male suture 320 may include a male locking zone 322 that may includelocking features 324. In some embodiments, the locking features may beon the bottom side of the sternal device. For example, the lockingfeatures may include ball shapes, cone shapes, bumps, teeth, jaggededges, holes, or grooves. The male locking zone may be long at leastpart of the length of the male suture where the male suture is likely toengage with the female locking zone.

FIG. 3D shows a lower perspective view of another embodiment of asternal device. A close up is provided of a male locking zone 330 fromthe bottom of the sternal device. A close up is also provided of afemale locking zone 332. The male locking zone may be guided into thefemale locking zone via the end of the male suture. The end of the malesuture may optionally include a delivery needle and/or engagement zone.

The male locking zone may include locking features such as ridges 334.The locking features may be shaped so that the male suture may pass moreeasily in one direction through the female locking zone than in theother direction. The female locking zones may or may not includecorresponding locking features within. In some instances, the femalelocking zone may have an outer surface and an inner surface. The innersurface may contact the male suture. The inner surface may compriselocking features that may correspond to the locking features of the malesuture and prevent or make it difficult for the male suture to move inat least one direction with respect to the female locking zone. Thefemale locking features may also be ridges, bumps, balls, grooves,hooks, bars, ratchets or anything similar.

FIG. 4A shows a sternum connecting device in accordance with anembodiment of the invention. The sternum connecting device may include acentral structure 400, a plurality of elongate members 402, and aplurality of lock devices 404. For example, a central structure may beconnected to two elongate members that may extend from the centralstructure. Two lock devices may be connected to the central structure.

In some embodiments, the elongate members may extend from one side of acentral structure while the lock devices may be provided on a secondopposing side of the central structure. For example, if elongate membersextend from a right side of a central structure, the lock device may beprovided on the left side of the central structure. Thus, the elongatemembers may be adjacent to one another, while the lock devices may beadjacent to one another. In other embodiments, the elongate membersand/or lock devices need not extend from the same side. For example anelongate member may extend from a right upper corner of a centralstructure, a lock device may be positioned on a right lower corner ofthe central structure, an elongate member extend from a lower leftcorner of the central structure, and a lock device may be positioned atthe upper left corner of the central structure. In such situations, theelongate members are not adjacent to one another and the lock devicesare not adjacent to one another.

In some embodiments, the take-off and degree of the male elongatemembers may be adjustable. This may allow the sternum connecting deviceto be placed in an optimal manner in relation to the ribs.

The female lock devices may be on an anterior or posterior surface ofthe central device. Alternatively, they may be provided on the side ofthe central device. The female lock devices may be fixed relative to thecentral structure, or may be pivotally connected to the centralstructure (e.g., by a pin). The female lock device can be attached tothe central structure via the central pin which may allow it to rotateto an optimal angle to accept the male elongate member. The female lockdevice may be shaped to accept a flat or round male elongate member. Thevarious profiles and shapes of the male elongate members may bediscussed in greater detail below. The female lock devices may be builtinto the central structure to be as smooth and low profile as possible.

The sternum connecting device may be low profile and simple. In someinstances, the central structure may be as flat as possible (lowprofile).

The sternum connecting device may utilize some of the similar principlesto traditional wire placement techniques. The sternum connecting devicemay allow for quick application, and may be easily cut in an emergency.Furthermore, the sternum connecting device does not need drills, screws,or plates.

In some instances, the sternum connecting device may have a potentialfor resorption. The sternum connecting device and/or any of itscomponents may be formed of a material that may be reabsorbed within thebody. The sternum connecting device and/or any of its components mayinclude an antibiotic coating or growth factor coating. Materialsassociated with the sternum connecting device may be discussed ingreater detail below.

FIG. 4B shows a sternum connecting device after a needle 410 is drawnthrough a female locking device 412. The needle may be connected to amale elongate member 414. The needle may be directly connected to themale elongate member or may be indirectly connected to the male elongatemember via a thread or line. The male elongate member may also have anengagement zone 416 that may have a conical or tapered shape that mayassist with guiding the male elongate member through the locking device.In some embodiments, the engagement zone may provide the same functionas the needle. In some instances, the engagement zone may be pointed,and may enable a user to thread the male elongate member through softtissue via the pointed engagement zone.

A central member 418 of the sternum connecting device may be placedproximate a sternum, wrapping a first one of the elongate members aroundthe sternum, and inserting it (e.g., via the needle and thread) througha first one of the locking devices such that it engages with the firstlocking device. The second elongate member can be wrapped around thesternum, inserted through the second locking device, such that itengages the second locking device. The delivery end of each elongatemember can be cut off after insertion through the locking device, e.g.,to make the elongate member flush with the locking device. For instance,a needle is cut off and the thread/elongate member pulled through thefemale locking device. Or the elongate member may be directly pushed orpulled through. In this manner, the apparatus may form a more robuststernal fixator that counteracts the various forces that are experiencedbetween the cut pieces of the sternum following a sternotomy.

The central core structure can have relaxing cuts in it to allow thefemale locking devices some wiggle or bend. This may provide breathingroom that may take some stress off the sternum connecting device.

FIG. 4C shows a sternum connecting device as a male elongate member 420is drawn through a female locking device 422. A first elongate memberhas already been inserted into a female locking device and the excesselongate member 424 cut off.

A needle 426 may be passed behind a rib and sternum. The needle may be astandard needle driver, such as in a standard wire, or any needle knownor later developed in the art. The needle may be connected to a line428, which may connect it to an elongate member. The needle may be cutoff and the thread and/or elongate member may be pulled through a femalelocking device.

Once engaged through the female, the excess male elongate member may becut off and discarded. A cutting device may also be used to tighten todevice to any appropriate force level desired.

Central Body

FIG. 5 shows an example of a central body shape 500. A central body mayinclude a plurality of stems 502 that may extend from a central regionof the central body. In some instances, the central body may besymmetrical about a central vertical axis and/or a central horizontalaxis. Any number of stems may extend from a central body. For example,two, three, four, five, six, eight, ten, twelve, or more stems mayextend from the central body. The stems may extend so that they aresubstantially evenly spaced out, or they may be spaced so that some arecloser to others, or that they are arranged in groups.

The stems may have any shape or dimensions. In some instances, the stemsmay be long and narrow, while in other instances they may be short andstubby. In some instances, the stems may barely protrude from thecentral region of the central body. In some instances, a central regionof the central body may be larger while in other instances the centralregion. In some embodiments, the central body may have a curvedcontoured shape, while in other embodiments, the central body may havemore abrupt or angular shapes.

Preferably, the stems may be integral to the central body.Alternatively, one or more stems may be separable from the rest of thecentral body. In some instances, one or more stem may connect to anotherstem, or may connect to a central region of the central body.

FIG. 6 shows another example of a central body shape. In someembodiments, the central region 600 of the central body may be elongatedso that the central body with the stems forms more of an “H” or “I”shape. In some instances, the stems 602 may be parallel or substantiallyparallel to one another. Alternatively, the stems may be substantiallynon-parallel to one another. The shape of the stems may be provided sothat parts of the stem are not parallel to one another, while otherparts are not. In some instances, the stems may be substantiallystraight, while in other instances they may be curved or bent. The stemsmay intersect one another or may intersect a central region of thecentral body.

The central body may be placed on a sternum so that the central bodyspans the midline 604 of the sternum. The stems of the central body maybe positioned between one or more ribs 606, and the associated costalcartilages 608. The stems may wrap around to at least a portion of thesides of the sternum.

FIG. 7A shows a central body 700 with elongated stems 702. The stems mayform an ‘X’ shape. In some embodiments, the stems may narrow as theyextend from a central region of the central body. Alternatively, theymay retain the same width and/or get wider as they extend from thecentral region of the central body. The central body may be asubstantially planar or curved planar body, as opposed to two or moreoverlapping planes or layers.

In some instances, the stems may wrap around at least a portion of aside of the sternum

FIG. 7B shows a central body with multiple layers 710 a, 710 b. In someinstances, a central body may include stems that may form a cross shapeas two elongated stem pairs may cross over one another. However, even ifstem pairs cross over one another, they may retain a low profile. Thus,in some embodiments, a central body may have two or more overlappingplanes or layers. In other embodiments, preferably, a central body mayonly have one layer.

FIG. 7C shows a central body 720 with shorter stems 722. In someinstances, the central body may be sized so that the stems do not wraparound a side of the sternum, but may be entirely on a front or back(anterior or posterior) side of a sternum. A central body may have anyshape, which may include an ‘X’ shape, ‘H’ shape, ‘I’ shape, ‘T’ shape,‘K’ shape, or ‘)(’ shape. One or more suture 724 may wrap around thesternum.

The central body may have any size. The central body may be roughlysized to fit a sternum. In some instances, the footprint of a centralbody may be on the order of W by H, where W represents a width dimensionand H represents a height dimension. The values for W and/or H may be onthe order of about 10 cm or less, 8 cm or less, 3 cm or less, 5 cm orless, 4 cm or less, 3.5 cm or less, 3 cm or less, 2.5 cm or less, 2 cmor less, 1.5 cm or less, or 1 cm or less. W and H may have about thesame dimensions, or may have differing dimensions. In some instances, acentral body size may be selected to fit a sternum. In otherembodiments, a body may be provided for a sternum, and aspects orcomponents of the size may be variable in order to be made to fit thesternum.

FIG. 8 shows a contoured central body of a sternal device. In someembodiments, a central body may have a low profile. The central body maybe contoured to fit the contour of a sternum. In some embodiments, asternum may include a convex region, and the central body may include acorresponding convex region. In other embodiments, the sternum mayinclude a concave region and the central body may include acorresponding concave region. In some instances the sternum may have acurved planar configuration. Thus, the central body may retain a lowprofile and conform as much as possible to the shape of the sternum. Bybeing low profile, the sternal may be not as palpable by a subject postoperation. One surface may correspond to the deep surface/posterior 800side and the other surface may correspond to the superficial/anterior802 side

In some embodiments, different central body sizes and/or configurationsmay be provided to fit different sternums. For example, a differentcentral body size and/or profile may be provided for a child as opposedto an adult. A central body size may be selected to accommodate thesubject.

In alternate embodiments, the central body may be relatively flat. Insuch situations, the central body may provide a flat surface around thesternum. Thus, in some instances, the central body may have asubstantially planar configuration. The central body may have anelongated shape.

In some instances, the material for the central body may be selected toassist with conforming to a sternum shape. The central body may bedesigned to minimize or reduce lift off the sternum. For example, thecentral body may be formed of a flexible material and/or have flexiblecomponents that may allow it to conform to the shape of a sternum. Inother embodiments, the central body may be rigid or semi-rigid, or mayhave rigid or semi-rigid features that may allow it to maintain adesired profile.

FIG. 9 shows a central body 900 of a sternal device with one or moreholes 902. In some instances, the central body may have holes that mayenable underlying bone tissue and/or soft tissue to grow in through theholes and/or develop through the holes. This may assist with anchoringthe central body into place. Better incorporation of the device onto theunderlying tissue may cause the device to be stronger.

A plurality of holes may be provided. In some instances, the holes maybe provided as an array, or in rows or columns, or with a concentric orstaggered pattern. Alternatively, the holes may have any placement. Insome instances, the holes may have any diameters, including holes on theorder of 2 cm diameters, 1 cm diameters, 0.75 cm diameters, 0.5 cmdiameters, 0.3 cm diameters, 0.2 cm diameters, 0.1 cm diameters, 0.05 cmdiameters, or 0.01 cm diameters. The holes may have the same ordifferent diameters.

FIG. 10 shows a central body 1000 of a sternal device with an irregulartextured surface 1002. The irregular textured surface may includesurface roughness, bumps, ridges, grooves, pits, or any other surfacefeature that may provide texture to the surface. In some instances, thecentral body of the sternal device may have microscopic undulations orother textured surface features. Providing an irregular textured surfacemay enable a bodily tissue, such as underlying bone tissue, and/or softtissue to grow into the surface irregularities. This may also assistwith anchoring the central body into place. Providing a bumpy boneinterface may give the sternum or other underlying anatomical featuresomething to grab ahold of, and assist with forming a fibrous bond.

In some embodiments, additional anchors may be provided to keep acentral body in place with respect to the sternum, or any otherunderlying anatomical structure. For example, drills, screws or similarfeatures may be used to anchor the central body.

FIG. 11 shows an artificial hip joint 1100 with an irregular texturedsurface 1102. The irregular textured surface may encourage a subject'sbody part to grow into the textured surface. These irregularities may besimilar to the irregularities that may be provided on a central body ofa sternal device.

The sternal device may be fitted to follow closely with a sternum shape,or the shape of any other underlying anatomical feature. By fitting thedevice to the sternum, the mechanical advantage may be increased. Forexample, this may prevent the device from shifting around with respectto the sternum. It may also help provide a consistent, tight fit, whichmay assist with healing. In some instances, it may be desirable for theunderlying tissue to hold onto a body of the sternal device. If asubject's patient can latch onto or grow into or form a fibrousattachment to the central body of the sternal device, the connectionwill become stronger, and the device may be more difficult to dislodge.

Loose Connections

The sternal device may be designed to fit a body of a subject, ratherthan making the body conform to the device. For example, a sternaldevice may fit around a sternum and may conform to the sternum of asubject.

In some embodiments, it may be desirable for there to be looseconnections between a central body of a sternal device and the malesutures. These loose connections may be provided where the male suturetakes off from the central body and/or where the male suture is receivedby the central body. Thus, a sternal device on the male and female sidemay be loose, or may have play to assist with setting the device intoposition. Once in proper position, the device may be tensioned. Astension increases, movement may decrease.

In some embodiments, a male and/or female base may be connected to amale and/or female stem respectively. At least one of the male or femalebases may be configured to enable a male suture to change orientation atthe male or female base with respect to the male or female stem to whichthe male or female base is connected. The male sutures may changeorientation at the male or female base within a restricted range. Themale or female base may have a low profile with respect to the rest ofthe central body.

FIG. 12 shows a relationship between tension 1200 and freedom of wiggle1202 generally for a sternal device joint. Typically, an inverserelationship is provided so that when tension is high, there is lessfreedom of wiggle, and when freedom of wiggle is high, there is lesstension.

Thus, when a sternal device is tightened about a sternum, the sternaldevice may conform to the shape of the sternum and/or other anatomicalfeatures without exerting stresses on the body that would be detrimentalto the body. As the tension is increased movement of the device may bedecreased. Therefore, once the device is tensioned to a desired amount,there may be little system movement that occurs. This may provide anoptimal healing environment for bone.

A suture may connect to a main body via a male or female base, or may bedirectly connected to a male or female stem. Any of these connectionsmay be integral or separable. For example, a suture may be snap fit intoa connection, screwed into a connection, crimped into a connection, maybe connected with an adhesive, may be clamped within a connection, maybe locked into a connection, may be melted into a connection, tied intoa connection, impaled into a connection, or connected in any othermanner.

FIG. 13 illustrates a suture 1300 connected to a main body. The suturemay be connected so that it may have a loose fit within the socket 1302.The socket may be a male socket and/or a female socket. The suture maybe provided within the socket so that when a load is applied to the maleand/or female side, the freedom of the system may stop and the suturewill not wiggle. This may provide a settled stability within the system.

The suture may have one or more degrees of freedom of wiggle. Forexample, the suture may be free to move up and down 1304 with respect tothe socket. The suture may also be able to move side to side 1306 withrespect to the socket. In some alternate embodiments, the suture mayalso move back and forth with respect to the socket. The loose fit mayassist with any of the degrees of freedom. The degrees of freedom may belimited to one, two, or more of the above.

The suture may be connected to the body with the socket so that thesternal device has a low profile. The socket might have a lower profileif it is flat or shaped like a flattened oval. It may or may not havefree range of motion like a ball and socket type joint. In someinstances, the connection might just have the ability to have a certainrange, such as 20 degrees in any direction.

FIG. 14 shows a sternal device body 1400 with male 1402 and female bases1404. The male and female bases may be configured to provide at leastone degree of freedom of movement for a suture that may extend from amale base and be received by a female base. A male suture may changeorientation at a male or female base within a restricted range. Forexample, a male suture may rotate side to side within a restrictedrange. Alternatively, the male suture may angle up and down within arestricted range. In some instances, the male suture may have freedom ofmotion within two dimensions (side to side and up and down) within arestricted range.

In some instances, a sternal device body may have a male side and afemale side. The male side may include male bases, and a female side mayinclude female bases. In some instances, the male side may be on oneside of a sternal device body about a vertical axis of the sternaldevice body and the female side may be on the other side of the verticalaxis. Alternatively, the male side may be on one side of a sternaldevice body about a vertical axis of the sternal device body and thefemale side may be on the other side of the vertical axis.

Male Connections

A male suture may take off from a male base of a central body of asternum repair device. The male base and/or male suture may beconfigured to allow the male suture at least one degree of movement withrespect to the male base and/or corresponding male stem.

FIG. 15 shows a male suture 1500 with a ball 1502 and socket 1504 jointin accordance with an embodiment of the invention. A male suture andmale base may form a ball and socket joint similar to a configurationused for a keychain with balls that may slip into a rounded holder. Themale suture may click into the male base and be secured within the malebase while having freedom to rotate within a limited range within theball portion of the base. In some embodiments, when a male suture isclicked in, it cannot be backed out. Alternatively, in some instances,it may be backed out in controlled situations.

FIG. 16 shows a male suture 1600 connected to a male base 1602 of asternum repair device. The male suture may rotate within the male basealong a limited range of degrees. For example, the male suture mayrotate to a left side, then to the middle, and then to the right. Usinga ball 1604 and socket time joint may advantageously allow such motionwithout providing sideways stresses on the device or body. It may allowsettling of the device once the device is tightened, so that it does notcause twisting of the central body or binding of the male/female mating.

In some instances, a ball and socket type joint may be round and have aspherical shape. Alternatively, variations may be provided with varyingdegrees of freedom where different shapes may be utilized, includingflat shapes and/or elliptoids. In some instances, the ball and socketjoint may have very small dimensions, e.g., such that a maximumdimension may be about 0.3 cm or less, 0.2 cm or less, 0.1 cm or less,0.07 cm or less, 0.05 cm or less, 0.01 cm or less, 0.005 cm or less, orabout 0.001 cm or less. Preferably, the male base and suture may have alow profile with respect to a sternum when used.

The ball and socket joint describe an embodiment where a male suture mayclick into a male base. Alternatively, the male suture may be integralto the male base.

If the male suture may click into the male base, this may advantageouslyallow customizable lengths of male suture to be placed. For example, insome instances, a user may need 18 inches vs. 12 inches of suture.Another advantage may be that the suture may be placed around thesternum and then clicked into the device. This may keep the body andother suture from flipping around while a user is operating. A separablemale suture may also provide increased potential for modular componentslike different body shapes with different suture lengths. In someinstances, this may also allow for easier packaging. Furthermore, it maysimplify production, e.g., if the body and male suture are moldedseparately. They may be joined at the factory, or may be shippedseparately.

If the male suture is integral to the male base, this may advantageouslyprovide a simplicity of design. This may also reduce the number of stepsassociated with assembly and installation into the body. Having a malesuture integral to a male base may also remove another possible point offailure or diminished performance, and may be cheaper to produce.

Although such a configuration may preferably be used for a male baseand/or connection, it or variations of it may be applied to a femalebase and/or connection as well. Similarly, any of the female connectionsdescribed or variations thereof may also be applied to male bases.

Female Connections

A male suture may be received by a female base of a central body of asternum repair device. The male base and/or male suture may beconfigured to allow the male suture at least one degree of movement withrespect to the male base and/or corresponding male stem.

FIG. 17 shows a female base 1700 of a sternal device in accordance withan embodiment of the invention. The female base may be on a female stem1702 of a central body 1704 of the sternal device. The female base mayswivel on the female stem. In some instances, the female base may havethe freedom to swivel completely around the female stem. In otherembodiments, the female base may only be configured to swivel within arestricted range. For instance, protrusions, or other stoppingmechanisms may be provided that may prevent the female base fromswiveling entirely.

The female base may have any shape that may accept the male suture.Although a rectangular or square shaped female base may be displayed,the female base may alternatively be shaped as a triangle, circle,ellipse, pentagon, hexagon, octagon, or any other regular or irregularshape. The female base may have rounded edges. In some instances, thefemale base may be contoured to not get caught on anything and allow asmooth turn.

FIG. 17 also shows a side view of the female base 1710. The female basemay be held in place by a pin or axis 1712 that may attach the femalebase to the female stem 1714. The pin may allow the female base toswivel around with respect to the stem. The pin may be fixedly attachedto the female base and may rotate with respect to the stem; the pin maybe fixedly attached to the stem and the female base may rotate withrespect to the pin; or the stem, pin, and female base may all rotatewith respect to one another. In some instances, the pin and the femalebase may be formed of one piece.

Preferably, the female base may have a low profile. In some instances,the female base may be disposed over the female stem. It may or may notoverhang part of the female stem. Alternatively, the female base may beprovided below the female stem, or may be within the female stem oradjacent to the female stem so that it does not protrude over or belowthe stem.

FIG. 18 shows a range of rotation for a female base 1800. For example,in some embodiments, the female base may rotate about 15 degrees to meetup with the male suture effectively. In other embodiments, any degree ofrotation may be permissible, which may include about 5 degrees, 10degrees, 20 degrees, 30 degrees, 45 degrees, 60 degrees, 90 degrees, 120degrees, 150 degrees, 180 degrees, 270 degrees, or 360 degrees ofrotation. In some instances, the rotation may only be provided on oneside, while in other embodiments, it may be provided on both sides.

FIG. 19A shows a female base 1900 on a female stem 1902, which may movealong a restrictive path relative to the stem. In some instances, thefemale stem may be elongated. The female stem may be flexible and thin.

A female base pivot 1904 may be provided which may allow some smalladjustments on the female side. The female base may be shaped to dependon the shape of the male suture. For example, if a flat male suture isprovided, the female base may have a flat shape. Alternatively, if around male suture is provided, the female base may have a round shape.The female base may be any shape that may receive the male suture. Insome instances, the female base may have an outer surface and an innersurface. In some instances, the shape of the outer surface and innersurface may match (e.g., both may be round, or both may be flat).Alternatively, the shape of the outer and inner surfaces may bedifferent (e.g., the inner surface may be rounded, while the othersurface may be provided a more flat, contoured shape). The inner surfaceof the female base may match the shape of a male suture.

FIG. 19B shows a side view of a female base 1910 on a female stem 1912.The female stem may be thin and/or flexible. In some instances, thefemale stem may bend or flex upwards and/or downwards. In someembodiments, the female stem may flex about 40 degrees upwards, and/ordownwards. In other embodiments, the female stem may flex about 5degrees, 10 degrees, 15 degrees, 20 degrees, 30 degrees, 35 degrees, 45degrees, 50 degrees, 60 degrees, or about 90 degrees upwards and/ordownwards. The stem may flex to fit the contour of a sternum and/or anyother anatomical feature.

In some instances, the stem may be constructed of a material that maybend, and then retain its shape after being bent. In such embodiments,the stem may be wrapped around to fit the contour of a sternum and thenmay retain that shape in the absence of outside force.

In some instances, a female base may only swivel from side to side. Insome instances, the female base may swivel about a pin 1914. In otherembodiments, the female base may also angle upwards or downwards withrespect to the female stem within a limited range.

FIG. 20 provides views of additional examples of female bases and stems.In one embodiment, a round female base may 2000 be provided on a femalestem 2002. This may be advantageous when a round male suture is used.The round female base may form a tube or cylinder. In other embodiments,the round female base may have a conical shape. Alternatively, the roundfemale base may form a loop or ring 2004.

In other embodiments, the female base 2006 may be integrated into a stem2008. In one example, the female base may be provided at an angle withinthe stem so that the male suture 2010 may pass through the stem. Anyangle may be provided, e.g., 5 degrees, 10 degrees, 15 degrees, 30degrees, 45 degrees, 60 degrees, 80 degrees, or 90 degrees.

For any of the embodiments described, a male suture may include malelocking features. A female base may have corresponding female lockingfeatures which may engage with the male locking features and restrictthe motion of the male suture in at least one direction. For example,the female base may be configured to accept the male suture so that themale suture can only pass through in one direction.

In other embodiments, the male suture need not include male lockingfeatures. The female base may include female locking features or anysort of retaining mechanism that may engage with the male suture andrestrict the motion of the male suture in at least one direction. Insome instances, the female retaining mechanism may prevent the malesuture from moving in either direction. For example, the femaleretaining mechanism may include some sort of clamp, teeth, crimp, pin orhook that may catch onto the male suture and hold it in place when sodirected by a user. Possible suture configurations are discussed ingreater detail below.

FIG. 21 shows an example of a tool 2100 that may be used to tighten amale suture 2102 along a female base 2104. The tool may be configured toboth tighten the male suture and to cut off excess suture so that it isflush with the female base. The tool may have a tightening mechanismwhich may draw the male suture through the female base a predeterminedamount and/or retain the male suture at its present position. Thus, itmay incrementally tighten the male suture. Alternatively, it may have amechanism that may allow it to continuously tighten the male suture. Thetool may also have a cutting mechanism which may cut through the malesuture. The cutting mechanism may be positioned on the tool to cut themale suture flush with the female base.

The tool may include a tension dial to dial in whatever tension isrequired. Alternatively, it could be inherent to the device.

When the male suture is tightened against the female base, the sternaldevice with flexible male and/or female bases may be configured to allowthe device to settle around a sternum (or other anatomical feature)without putting too much stress on the device or the surrounding body.

Although such a configuration may preferably be used for a female baseand/or connection, it or variations of it may be applied to a male baseand/or connection as well. Similarly, any of the male connectionsdescribed or variations thereof may also be applied to female bases.

Suture

A suture of a sternal device may have any configuration. Preferably, thesuture may be formed of a flexible material. Alternatively, the suturemay include rigid and/or semi-rigid components. The suture may beconfigured to bend sufficiently to wrap around a sternum or part of asternum.

The suture may preferably be formed of a material with sufficienttensile strength to hold together a split sternum and/or otheranatomical features. The suture may or may not be configured to stretchwhen tightened.

The suture may have any major diameter size that may allow it to wraparound the sternum. For example, a diameter of the suture may be about0.7 cm or less, 0.5 cm or less, 0.3 cm or less, 0.2 cm or less 0.1 cm orless, 0.07 cm or less, 0.05 cm or less, 0.03 cm or less, 0.01 cm orless, 0.005 cm or less, or about 0.001 cm or less.

The suture may have any cross-sectional shape. For example, the suturemay have a substantially circular cross sectional shape. Alternatively,it may have an elliptical cross sectional shape, rectangular crosssectional shape, square cross sectional shape, or by substantially flat,like a tape.

In some embodiments, a suture may have any lengths. In some instances,all of the sutures for a sternal device may have the same length, whilein other instances, the length at least one suture may vary. In someinstances, suture may be selected at a desired length and then connectedwith a male stem or base to customize the device to the subject. Someexamples of suture lengths may include sutures that are about 100 cmlong, 80 cm long, 70 cm long, 60 cm long, 50 cm long, 40 cm long, 35 cmlong, 30 cm long, 25 cm long, 20 cm long, 15 cm long, 12 cm long, 10 cmlong, 8 cm long, or 5 cm long.

Suture materials may have any desired material property, which mayinclude a desired strength, stiffness, flexibility, or elasticity of thesuture. For example, the suture may be elastic like a bungee cord typematerial. Otherwise, it may stretch less, like a thread or string-likematerial. In some instances, the suture may be formed of a wired orbraided structure, which may include wires or fiber.

In some embodiments, the suture may have a substantially smooth surface.Alternatively, the suture may have a texture surface and/or lockingfeatures. The textured surface and/or locking features may run along theentire length of the suture, or only along one or more selected portionsof the suture. In some instances, the selected portions may be toward afirst end of the suture or a second end of the suture.

FIG. 22 shows examples of various possible suture configurations. Insome examples the suture may have locking features 2200 such as ballshapes, cylindrical or circular shapes, pointed conical shapes, barbs,roughening, knurling, protrusions, indentations, grooves, ridges, teeth,or any other shape. In some instances, some of locking features (e.g.,bumps, teeth or ridges) may be buried so that they do not protrude fromthe suture. The suture itself may be round or elliptical with hiddenlocking features which may prevent them from catching on tissue. Forexample, the suture may include one or more large channel orindentation, in which locking features may be provided. In someinstances, the suture may include one or more linkages, like a chain.

FIG. 23 provides an additional example of a suture configuration 2300.In some embodiments, a suture may be inlayed with fibers, fine wire,mesh, or other additives which may increase the strength of the suture,and thereby the sternal device. Additives may make the suture stiffer tolongitudinal forces and/or provide any other desired materialproperties, such as stiffness, flexibility, strength, or elasticity tothe suture. In some instances, the fibers or other additives may be likemesh used in other applications. It may allow strength without limitingor minimally impacting flexibility.

Such additives may run within the substance of the suture or maybeprovided along the surface of the suture.

A suture may be connected to another suture or to a base by varioustechniques. For example, a suture may be connected to another suture orother component via crimping, soldering, gluing, wedges, lockingfeatures, via a sleeve, a shim, an adhered portion, a heat deformedportion, or a melted portion.

Device on Sternum

In accordance with an aspect of the invention, a sternum repair devicemay be applied on a sternum of a subject. A subject may be human oranimal, and may be a patient, or may be involved in testing or research.The sternum repair device may be provided after a sternotomy, when asplit sternum has been provided. The sternal device may wrap around thesplit sternum, to allow the sternum to heal and grow back together.

In alternate embodiments, the sternum repair device or variation thereofmay be applied to other similar anatomical features of a subject. Suchanatomical features may include a split bone. The sternum repair devicemay wrap around any tissue (bone tissue or soft tissue) which mayrequire a device to wrap around it to hold it together and/or allow itto heal together.

FIG. 24 shows an example of forces at play on separate pieces of asternum after a sternotomy. Some examples of such forces arecephalad/caudal 2400, anterior/posterior 2402, or lateral 2404 forces.

Preferably, one or more of these forces may be neutralized or reducedusing a sternum repair device, to encourage the bone to heal together.Preferably, the sternum repair device will substantially immobilize theseparate sternum pieces together.

FIG. 25 provides an example of a sternum connecting device disposed on asplit sternum 2502. A median sternotomy may have occurred, where thesternum may be split along the middle of the sternum. A central body2500 of the sternum connecting device may be placed on an anterior sideof a sternum. One, two, or more male elongate members 2504 may extendfrom the central body, wrap around the posterior side of the sternum andconnect to the central body on the anterior side of the sternum. Theelongate members may be tightened to hold the separate pieces of thesternum together.

In some embodiments the sternum connecting device may span one, two, ormore sets of ribs. In FIG. 25, the sternum connecting device spans twosets of ribs.

FIG. 26 shows an example of a sternal device with flexible componentsthat can be disposed in a body. The sternal device may have a centralpiece 2600 with one or more male bases 2602 and one or more female bases2604. A male suture 2606 may extend from a male base and be received bya female base. The male suture may wrap around the sternum 2608. In someinstances, the male suture may be positioned to wrap around the sutureso that it passes over a rib or under a rib 2610.

The male and/or female bases may be configured to allow the male sutureto change orientation at the male or female base with respect to thecentral body to which the male or female base is connected. In oneexample, two male bases may be provided and two female bases may beprovided. The male bases may utilize a ball and socket type connection.The female bases may utilize a swivel type connection. Alternateloose-fitting or movable connections may be utilized.

The male suture may be flexible. In some instances, it may be about 2-3mm in diameter. The male suture may include locking features, such asteeth, which may engage with the female base. The male suture may alsoinclude an engagement zone, which may narrow the male suture. Theengagement zone may or may not include locking features. In someinstances, the engagement zone does not have teeth so that it rightsitself into the female base.

Optionally, a needle may also be provided. The needle may be connectedto the engagement zone or the male suture.

FIG. 27 provides a view from a bottom of a subject's body to view aprofile of a sternal device 2700. The view may be provided when lookingat a patient from a foot of a bed, when the patient is lying on hisback. The device may preferably have a shape that may mirror the contourof the sternum. This may be contrasted with an alternate embodiment thatmay utilize a flat piece.

Preferably, the contoured device may have a low profile with respect tothe sternum. Any male and/or female parts may also be configured not toprotrude from the device by a large amount and/or may be contoured tominimize or reduce internal irritation. In some instances, the male 2702and/or female 2704 base may be positioned over the side of the sternum.In such situations, the male suture may interact with the central bodyon the sides so that they are not on the anterior or posterior side ofthe sternum. Alternatively, they may be along an anterior surface or aposterior surface of the sternum. Thus, male and/or female stems may ormay not go over the edge of a sternum to hide, so that the subject neednot feel the device on the male or female side. When the male and/orfemale engagement mechanisms are out over the edge of the sternum, theymay be hidden from palpation. The male and/or female base may beconfigured so that they are under a central body portion of the sternum,so that they may at least lie partially between the sternum and anexterior portion of the central body.

FIG. 28 shows a sternal tissue connecting device on a sternum inaccordance with another embodiment of the invention. The tissueconnecting device may be positioned to connect separate pieces of thesternum. In some instances, elongate members 2800 may extend from acentral body 2802 and wrap around the sternum 2804. The angle created bythe elongate members as they extend from the central body may bevariable. This may depend on the number and/or size of ribs 2806 thatthe device spans. The angle may be variable within human anatomy. Thismay allow a built-in customization of the sternal tissue connectingdevice.

Some examples of the angle that may be created by the sutures mayinclude 5 degrees, 10 degrees, 15 degrees, 30 degrees, 45 degrees, 60degrees, or 75 degrees. If a greater number of ribs are spanned or thecentral body is smaller, the angle may be increased.

Sternal Device Variations

FIG. 29A shows an example of a sternal device 2900 spanning one set ofribs 2902. A system for connecting tissue may be provided. In someembodiments, the central body of a sternal device may be fitted to spanone set of ribs. The stems may be at a length, where the sutures may beused to span one set of ribs.

FIG. 29B shows an example of a sternal device 2910 spanning two sets ofribs 2912, 2914. In some embodiments, the central body of the sternaldevice may be fitted to span two sets of ribs. For instance, the stemsprovided on the central body may be longer when used to span two set ofribs, than for a central body used to span one set of ribs.

In some embodiments, the stems may be integral to the central body. Thecentral body may be selected to fit a particular sternum. For example,larger central bodies may be selected to fit a larger sternum.Alternatively, the stems may be separable from a central region of thecentral body, or from one another. In such situations, different sizesor shapes of stems may be swapped out to accommodate sternum sizesand/or arrangements. In some instances, the length of a stem itself maybe adjustable to fit the desired sternum. For example, the stem may havea sliding and locking feature, or some sort of telescoping feature thatmay enable it to change lengths.

In other embodiments, the angles of the stems with respect to oneanother may be adjustable. For example, the stems may be attached to oneanother or to a central region such that their angles or positions canbe adjusted. In some instances, angles or positions may be adjustedwithin a limited range.

The separable pieces may be lock-fitted together, or may snap together,screw together, or come together in any other mechanical manner. In someinstances, a stem may be selected to match the sizes of the other stems,while in other embodiments, a stem may be selected to match ananatomical feature, which may or may not result in it matching the otherstems.

Stems may also be selected of the same or varying materials. In someinstances, it may be more desirable to have a more flexible stem whilein other embodiments it may be more desirable to have a more rigid stem.

In other embodiments, the same central body may be utilized for varioussternum sizes and/or rib spanning or other application techniques. Thesuture size and/or arrangement may vary to accommodate different sizesor ranges. This may provide restricted freedom, which may allow a userto space different rib widths, which allows use on various patient bodytypes, and allows insertion to be easier.

FIG. 30 shows an example of a sternal device 3000 spanning two ribs3002, 3004 on a sternum 3006. A sternal device may be placed to span anynumber of ribs or any placement of ribs. In some instances, one, two, ormore sternal devices may be utilized following a sternotomy.

A system for connecting two tissues, such as two bone tissues of a splitsternum may include a central body which may have a plurality of malestems and a plurality of female stems. Optionally, the central body mayinclude a plurality of male bases connected to the male stems and aplurality of female bases connected to the female stems. The system mayalso include a plurality of male sutures, wherein the male sutures maytake off from a male base of the central body, wrap around two tissues(such as separate pieces of a sternum) and is accepted by a female baseof the central body.

In some embodiments, at least one of the male stems, male bases, femalestems, or female bases may be separable from the central body. In someembodiments, at least one of the male stems, male bases, female stems,or female bases may be replaceable with corresponding components ofdifferent size. For embodiments with longer stems, the stems may be“clip on” or “snap on” to facilitate placement. Alternatively, the maleand female stems may be integral to the central body.

FIG. 35 shows an example of a linking bar system in accordance with anembodiment of the invention. A linking bar may simulate an externalfixator on the sternum.

In some embodiments, a plurality of sternal devices 3500 a, 3500 b, 3500c may be provided. The sternal devices may connect pieces of a sternum3502 and span different sets of ribs 3504 a, 3504 b, 3504 c. A linkingbar 3506 may connect the plurality of sternal devices. In someembodiments, the linking bar may be connected to the central body of asternal device via a locking mechanism 3508 a, 3508 b, 3508 c.

In some embodiments, a single linking bar may be used to connect all ofthe sternal devices in a subject. In another embodiment, multiplelinking bars may be used to connect multiple sternal devices. In someembodiments, one, two, or more linking bars may be provided betweensternal devices. Correspondingly, one, two or more linking bar lockingmechanisms may be provided on a sternal device. In some embodiments, thelinking bar may be made from a soft or hard material, and may serve tolink the two central bodies together. In some embodiments, the linkingbars may be formed of or incorporate other materials described elsewhereherein. The linking bar may have an elongated shape. In someembodiments, the linking bar may include teeth, bumps, grooves,ratchets, holes, protrusions, or any other surface feature that mayassist with interfacing the linking bar with the locking mechanism. Thelocking mechanism may include corresponding features that may allow thelinking bar to be retained. In some embodiments, tension may or may notbe exerted on the linking bar.

In some embodiments, the linking bar may be applied so that it runsparallel or substantially parallel to the sternum. Alternatively, it maybe applied so that it is at an angle to the sternum. If a plurality oflinking bars are applied, they may be parallel to one another.Alternatively, they may be at an angle to one another or may cross overone another. In some instances, a linking bar may be parallel orsubstantially parallel to a split in the sternum.

A linking bar system may simulate a complex weave closure to provideadditional stability to the sternum and distribute forces across theconstruct. It may have a flat geometry. In some embodiments, it may beheld together with a similar mechanism as the closure. It may be appliedafter all of the sternal devices are in place. Alternatively, it may beapplied as sternal devices are being applied, or pre-applied before thesternal device is applied to the sternum.

Materials for Device

The various components of the sternal device may be manufactured fromany material with desired material properties. For examples, any of thecentral body, the male stems, the female stems, the male bases, thefemale bases, the male sutures, the male engagement zones, or deliveryneedle may include components formed from metal (e.g., steel, iron,aluminum, copper, silver, gold, titanium, etc. or combinations or alloysthereof), plastic, rubber, thread, or so forth.

In some embodiments, different degrees of stiffness, flexibility, orother material qualities may be desired for different components. Forexample, for a central body, it may be desired for the shape to be firm,stiff, or molded. Alternatively, it may be desired to be flexible. Insome instances, it may be desirable for stems of the central body to bemore flexible than the central region of the central body. In someinstances, it may be desirable for male sutures to be more flexible thana central body.

The components may be formed of biocompatible material. In someinstances, the components may be formed of materials that may bedesigned to be reabsorbed into the body.

In some instances, any of the components may include antibiotics orgrowth factors that may be applied to the components and extrude fromthe components. In some instances, substances, such as antibiotics,antiviral or growth modulators, and growth factors may be distributedthroughout the components so that they are constantly being extrudedinto the surrounding body, or that they are being extruded after acertain amount of time has passed. In some embodiments, the antibioticsor growth factor may be provided in materials that may gradually bereabsorbed by the body over time. As materials degrade or are absorbed,such treatments may be extruded. Such configurations may assist with thedelayed or prolonged extrusion of particular antibiotics or growthfactors.

For example, further during production or post-production, certainmodulators may be used. These can be “given off” by a suture as itdegrades. This may help improve healing or regard bacterial growth. Suchwound modification techniques may assist with fibroid regrowth or thehealing of various tissues. This may assist with preventing thedevelopment of a biofilm about the device. This may also help preventinfections or suture abscesses when the sternal device is applied.

In some embodiments, one or more components of the sternal device may beformed of a material that may become more malleable when warmed (e.g.,Lactosorb). In such situations, after a device is positioned along adesired anatomical feature, such as a sternum, it may be heated up andpressed down to make it conform to the shape of the anatomical featureand/or make it more low profile (e.g., smooth out a higher part).

Method of Using Sternal Device

Any of the embodiments of a sternal device may be applied to a body. Amethod of connecting two tissues may include one or more of thefollowing steps. A connection device may be provided where theconnection device includes a central body and a plurality of malesutures. The central body may have a plurality of male stems, aplurality of female stems, and plurality of female bases connected tothe female stems. Optionally, the central body may also have a pluralityof male bases connected to the male stems. The male sutures may beconnected to and extend from a male stem, whether it be directly fromthe male stem or indirectly via a male base. The male and female stemsmay extend from a common central point of the central body.

A first male suture may be wrapped around two tissues and may beconnected to a first female base. In some embodiments, the two tissuesmay be bone tissue. The two tissues may form parts of a sternum. Asecond male suture may also be wrapped the two tissues, and may beconnected to a second female base. The first male suture and/or thesecond male suture may be tightened to fit around the two tissuessnugly. For instance, they may be tightened to finger-tightness.Optionally, they may be further tightened using a device or mechanism.In some embodiments, when the first and second male sutures are wrappedaround the two tissues, they may cross one another. In otherembodiments, they do not cross one another.

In some embodiments, in order to wrap around the two tissues, at leastone of the first male suture or second male suture may pass through softtissue. Preferably, the device will not be penetrating of bone-tissue.

In accordance with an aspect of the invention, one technique may includethe following steps to position a sternal device around a sternum.

First, a standard needle driver may be used to pass the needle from ananterior side to a posterior side near a rib 3106 on a first side. Theneedle may be retrieved posterior and the device may be begun to bepulled through. FIG. 31A shows an example of a needle 3100 passingthrough. The needle may be attached to a suture 3102 which may beattached to a central body 3104. Alternatively, the suture itself mayhave an integral pointed end that may function as a needle. In someinstances, the integrated pointed end may be formed of a harder or morerigid material than the rest of the suture.

Second, the male suture may be passed through the tissue lateral to thesternum near the rib in the same manner.

Third, both sutures may be pulled through to where the male baseapproaches the sternal-rib horizon. In some embodiments, the sutures maybe pulled through so that one suture crosses over another suture.Alternatively, they may be pulled through so that they do not contactone another.

Fourth, the needle driver may be reapplied to the needle and the needlemay be driven on a second side of the cut sternum in a posterior toanterior direction. FIG. 31B shows an example of this step. The needle3110 may they be retrieved anterior and the suture 3112 may be pulledthrough. This act may be repeated for one or more sutures on the otherside of the ipsilateral rib.

Next, the needle need not be cut off at or near the needle/engagementzone area and discarded. However, in some embodiments, the needle may beremoved at this step.

The engagement zone of a first male suture may be fitted into anappropriate female base and engaged. Once engaged, it may not bereversed. The male suture may then be continuously engaged until thedevice is tightened to a desired degree. In other embodiments, the malesuture is not engaged until the device is tightened to a desired degree.In some instances, the desired degree may be when the device is fingertight. A second suture and/or any other additional sutures may beengaged in this manner.

The central body may be properly positioned so that it is in goodposition on the sternum and not warped or twisted and the shaped bodymay lie congruent with the sternum. Optionally, the female base may bepositioned near the rib/sternum horizon to limit the palpability of thefemale base.

The male suture may be engaged with force until the sternum is properlyclosed. The male suture may or may not be pulled by a tension gun orother device or mechanism to achieve closure.

Once the sternum is in a proper position and male engagement is tight,then excess male suture distal to the female base may be trimmed anddiscarded.

In accordance with another embodiment of the invention, a technique forapplying a sternum connecting device may be provided. A drive needle maybe driven through intercostal tissue (which may be tissue between tworibs). In some embodiments, the drive needle may be attached to asuture. Alternatively, the drive needle may be an integral part of thesuture, or may be a pointed end of the suture. FIG. 32A illustrates aneedle 3200 being driven through tissue 3204 between two ribs 3202 a,3202 b. This may assist with connecting a split sternum 3206.

FIG. 32B illustrates an additional step to place a sternum connectingdevice on a sternum. The needle 3210 may be driven through intercostaltissue 3212 on the other side of the sternum. The suture 3214 may bedrawn through the intercostal tissue on the first side and around aposterior side of the sternum 3216 a. A central body 3218 may bepositioned on an anterior side of the sternum 3216 b. In alternateembodiments, the central body may be positioned on the posterior side ofthe sternum while the suture may be drawn around the anterior side ofthe sternum. The suture may include a locking zone 3220 and/or anengagement zone 3222 that may be attached to the needle.

FIG. 32C illustrates how a sternum connecting device may be used toconnect a sternum. In another step, the needle 3230 may be insertedthrough a female locking zone 3232 on a central body.

As a male suture is drawn through the female lock, an orientationfeature (e.g., guiding channel molded into an engagement zone) mayautomatically orient the male locking features to the female lockingfeatures. In other embodiments, orientation features may not be neededand the male locking features may be able to engage with the femalelocking features, regardless of how the male suture is oriented.

The male suture may be passed through the female locking zone until thedevice is secure and the two halves of the sternum are closed. The malesuture may be passed through to create a desired degree of tightnessaround the sternum.

FIG. 32D shows how the needle 3240, engagement zone 3242, and any excessportion of the male locking zone 3244 may be trimmed off. For example,the device may be wrapped around the sternum 3246, and excess malesuture may be cut off near the female lock 3248.

In accordance with some embodiments of the invention, such techniquesmay be applied with multiple sternal devices to capture multiple ribs.For example, in some embodiments, about four devices may be utilized. Insuch situations, all needles may be driven across one half of thesternum. For example, if four devices are used, and each device has twosutures, eight male sutures may be driven across a split sternum.Following that, each male suture may be inserted into its respectivefemale locking zone. In alternate embodiments, each male suture may bedriven across a split sternum and inserted into its respective femalelocking zone, one at a time. Alternatively, the order of these steps maybe modified so that any number of sutures are driven across and insertedinto a female locking zone.

Each suture may be hand tightened. The male suture may be pulled throughas much as possible. At this point, the male locking zone may be engagedwith the female locking zone. In alternate embodiments, a femaleretaining mechanism may be implemented to engage with a male suture,whether the male suture has a locking zone or not.

FIG. 33 shows a tensioning gun 3300 that may be used to tighten asternum connecting device. The tensioning gun may be used to tighten asuture and/or cut it. In one implementation, the tensioning gun mayinclude handles and jaws.

FIG. 34 shows how a tensioning gun 3400 may be used to tighten a sternumconnecting device. As previously described, the jaws 3402 may close onthe male suture 3404 beside the female lock 3406. The user may thensqueeze the handles 3408. As the handles are squeezed together, the jawsmay close on the male suture next to the female lock, pull it through afew more millimeters and then cut it. The handles may be squeezed toadvance the suture in a ratchet-like fashion through the female lock. Insome embodiments, the tensioning device may automatically cut the sutureafter the handles are squeezed. In other embodiments, other controls maybe provided to cause the actual cutting step.

Sternal Device Kits

Another aspect of the invention further provides for a sternal devicekit comprising the sternal device, which may comprise the central bodyand/or male sutures as discussed previously and instructions for usethereof. The kit may include one or more packages including one or moresternal device. The sternal devices may be disposable, so that they canbe easily replaced after a given amount of use, or may have a one-timeuse. In some embodiments, various different sizes or configurations ofsternal device may be available. Such varying sternal deviceconfigurations may allow a user to select an appropriate sternal devicefor a given subject or situation. In some embodiments, sternal devicesmay be individually packaged or may be packaged together.

The kit may also include a tool for placing the sternal device within asubject, such as a device to tighten the sternal device and/or cut offexcess sutures. The kit may also include any tools that may be helpfulto position the sternal device and/or penetrate soft tissue using adelivery needle. In some instances, a delivery needle and/or male suturemay be provided as part of the sternal device, or separately from thesternal device. Furthermore, in other embodiments one or more stems maybe provided as part of the central body of the sternal device, or may beprovided separately to allow a user to select a stem to fit a desiredsubject. The devices or tools may include one or more components, whichmay or may not be included within the kit. Also, the various tools ordevices, may be separate from the sternal device, and may or may not beincluded in the kit.

The kit may be conveniently packaged and may be commercially available.The kit may also include written, audio, or video instructions for useor maintenance of items therein.

FIGS. 36A-36E show various additional exemplary embodiments of tissueconnecting devices that may be used to close portions of a sternum aftera sternotomy, according to aspects of the invention. FIG. 36F shows acut feature that may be used with any of the embodiments shown in FIGS.36A-36E. Each of the embodiments shown in FIGS. 36A-36E is integrallyformed and may be constructed from a single piece of material. Eachdevice is shown in the configuration it would take when implanted arounda sternum, with bands inserted through the buckles, tensioned and distalends cut off.

FIG. 36A shows an integrally formed tissue connecting device 3610.Device 3610 includes a central body 3612. In this embodiment, two straps3614 are integrally formed with and extend from one end of central body3612 at non-parallel angles. A buckle 3616 may be integrally formed onthe distal end of each strap 3614, as will be subsequently described inmore detail. On the opposite end of central body 3612, two bands 3618are integrally formed with and extend from central body 3612 atnon-parallel angles. Bands 3618 are configured to encircle a sternum andbe received through buckles 3616.

In the embodiment shown in FIG. 36A, bands 3618 cross each other on theposterior side of the sternum and are received through the buckles 3616that are diagonally opposite the central body 3612 from where the band3618 takes off. In this configuration, the device forms an X shape andcan be referred to as a “Figure 8”. When device 3610 is installed on asternum, straps 3614 may be located on opposite sides of a rib, or maybe located between two ribs. Similarly, bands 3618 may be located onopposite sides of a rib, or may be located between two ribs. When straps3614 and bands 3618 are located on opposite sides of a pair of laterallyopposing ribs, such as depicted in FIG. 29A, device 3610 is generallybetter positioned to counteract cranial-caudal shear forces that occurbetween laterally opposite sides of the sternum. Straps 3614 and bands3618 may also be positioned to encompass multiple pairs of laterallyopposing ribs, as depicted in FIG. 29B.

Device 3610 may be provided with a circular view window 3620 throughcentral body 3612 as shown. View window 3620 may be used by a surgeon toline up device 3610 during installation on a sternum. In particular, acut line between two portions of a separated sternum or other tissue maybe viewed through view window 3620. Device 3610 may then be centeredover the cut line. Other view window configurations may be provided,such as oval, square, rectangular or other window shapes. The viewwindow may be non-symmetrical. In some embodiments, multiple viewwindows are provided which may be separated by one or more structuralportions.

FIG. 36B shows another example of an integrally formed tissue connectingdevice 3622. Device 3622 includes a central body 3624. In thisembodiment, two straps 3626 are integrally formed with and extend fromone end of central body 3624 parallel to one another. A buckle 3616 maybe integrally formed on the distal end of each strap 3626, as will besubsequently described in more detail. On the opposite end of centralbody 3624, two bands 3628 are integrally formed with and extend fromcentral body 3624 parallel to one another. Bands 3628 are configured toencircle a sternum and be received through buckles 3616.

In the embodiment shown in FIG. 36B, bands 3628 remain parallel to eachother as they pass around the posterior side of the sternum and arereceived through the buckles 3616 that are on the same side of centralbody 3624 from where the band 3628 takes off. In this configuration, thedevice forms an H shape and can be referred to as a “Figure H”. Whendevice 3622 is installed on a sternum, straps 3626 may be located onopposite sides of a rib, or may be located between two ribs. Similarly,bands 3628 may be located on opposite sides of a rib, or may be locatedbetween two ribs. When straps 3626 and bands 3628 are located onopposite sides of a pair of laterally opposing ribs, such as depicted inFIG. 29A, device 3622 is generally better positioned to counteractcranial-caudal shear forces that occur between laterally opposite sidesof the sternum. Straps 3626 and bands 3628 may also be positioned toencompass multiple pairs of laterally opposing ribs, as depicted in FIG.29B.

Device 3622 may be provided with an hourglass shaped view window 3630through central body 3624 as shown. View window 3630 may be used by asurgeon to line up device 3622 during installation on a sternum. Inparticular, a cut line between two portions of a separated sternum orother tissue may be viewed through view window 3630. Device 3622 maythen be centered over the cut line. Other view window configurations maybe provided, such as oval, square, rectangular or other window shapes.The view window may be non-symmetrical. In some embodiments, multipleview windows are provided which may be separated by one or morestructural portions.

FIG. 36C shows another example of an integrally formed tissue connectingdevice 3632. Device 3632 includes a central body 3634. In thisembodiment, a strap 3636 is integrally formed with and extends from oneend of central body 3634. A buckle 3616′ may be integrally formed onstrap 3636, as will be subsequently described in more detail. On theopposite end of central body 3634, two bands 3638 are integrally formedwith and extend from central body 3634 at a non-parallel angle to eachother. Bands 3638 are configured to encircle portions of a sternum andmay both be received through a single buckle 3616′.

In the embodiment shown in FIG. 36C, bands 3638 diverge from each otherat one end of central body 3634 and converge at the opposite end ofcentral body 3634. In this configuration, the device forms a Y shape andcan be referred to as a “Figure Y”. Device 3632 may be used to reconnecttwo or more portions of a sternum after a partial sternotomy, as will besubsequently described in relation to FIG. 39. In such a procedure,bands 3638 may pass through holes formed in the sternum rather thanpassing around the periphery of the sternum.

Device 3632 may be provided with a curved, trapezoidal view window 3640through central body 3634 as shown. View window 3640 may be used by asurgeon to line up device 3632 during installation on a sternum. Inparticular, a cut line between two portions of a separated sternum orother tissue may be viewed through view window 3640. Device 3632 maythen be centered over the cut line. Other view window configurations maybe provided, such as oval, square, rectangular or other window shapes.The view window may be non-symmetrical. In some embodiments, multipleview windows are provided which may be separated by one or morestructural portions.

FIG. 36D shows another example of an integrally formed tissue connectingdevice 3642. Device 3642 includes a central body 3644. In thisembodiment, a strap 3646 is integrally formed with and extends from oneend of central body 3644. A buckle 3616 may be integrally formed on thedistal end of strap 3646, as will be subsequently described in moredetail. On the opposite end of central body 3644, a band 3648 isintegrally formed with and extends from central body 3644. Band 3648 isconfigured to encircle a sternum and be received through buckle 3616. Inthis embodiment, strap 3646, central body 3644 and band 3648 areessentially a single band that may have a constant width and thickness.

FIG. 36E shows another example of an integrally formed tissue connectingdevice 3652. Device 3652 includes a central body 3654. In thisembodiment, a strap 3656 is integrally formed with and extends from oneend of central body 3654. A buckle 3616 may be integrally formed on thedistal end of strap 3656, as will be subsequently described in moredetail. On the opposite end of central body 3654, a band 3658 isintegrally formed with and extends from central body 3654. Band 3658 isconfigured to encircle a sternum and be received through buckle 3616.

Device 3652 may be provided with an oval shaped view window 3660 throughcentral body 3654 as shown. View window 3660 may be used by a surgeon toline up device 3652 during installation on a sternum. In particular, acut line between two portions of a separated sternum or other tissue maybe viewed through view window 3660. Device 3652 may then be centeredover the cut line. Other view window configurations may be provided,such as circular, square, rectangular or other window shapes. The viewwindow may be non-symmetrical. In some embodiments, multiple viewwindows are provided which may be separated by one or more structuralportions.

FIG. 36F shows an offset feature 3662 that may be used in any of thedevices shown in FIGS. 36A-36E or any of the devices described herein.In the example shown in FIG. 36F, offset feature 3662 is created in aband, strap or central body portion by forming an arcuate portion 3664between two bend lines 3666 and 3668. This arrangement causes arcuateportion 3664 to be raised above the adjacent device portions, leaving agap between arcuate portion 3664 and underlying tissue. The gap may beused to allow a portion of a cutting instrument to be placed between thedevice and a sternum or other underlying tissue, thereby allowing theband, strap or central body portion to be more easily cut with thecutting instrument. Cutting and removing the device may be needed whenit is desired to reposition or replace the device, remove the deviceafter tissue healing, or during a later planned or emergency procedure.

In some embodiments, offset feature 3662 may be configured to providethe device with a more resilient spring force. For example, when apatient coughs, rolls on his side in bed, or otherwise puts an increasedmomentary force on the closure device, the material of a traditionalclosure device may exceed its yield strength and elongate, bite into theunderlying tissue, or its position may slip. Such activity can causetraditional closure devices such as wire to break or become loose.Offset feature 3662 on the other hand can allow the closure device tomomentarily expand to accommodate the extra force, and then resume itsdesired size and the load it places on the underlying tissue. Suchresiliency can also allow the device to maintain the desired amount ofpressure on the underlying tissue despite “tissue creep” that can occurduring healing.

In some embodiments, a single offset feature 3662 may be used on thedevice, or multi offset features may be used. Multiple offset featuresmay be placed side by side and/or on opposite sides of the device. Theshape of the offset feature may be arcuate as shown, or an inverted U,inverted V, square, rectangle, triangle, inverted triangle, Z-shape,omega, or other shape or combination of shapes. The arcuate shape shownin FIG. 36F has the advantages of being low profile, and with no sharpfeatures to disrupt adjacent tissue.

As shown in FIGS. 36A, 36B, 36D and 36E, each of the closure devices maybe configured so that the buckle or buckles 3616 are located at leastpartially on a lateral side of the sternum, rather than on the anteriorface of the sternum. This arrangement keeps the buckles from protrudingoutward toward the patient's skin, which can cause irritation and/ortissue damage as the skin is pressed against the device and/or moveslaterally relative to the device. In some embodiments, a strapconnecting a buckle to a central body may be relatively long, as shownin FIGS. 36A, 36B, 36D and 36E, may be short as shown in FIG. 36C, ormay be non-existent with the buckle built directly into the centralbody.

Before being implanted, the devices shown in FIGS. 36A-36E may beprovided with straight or curved delivery needles (not shown in thesefigures) mounted on the ends of each band, as will be subsequentlydescribed in further detail. After being used to thread the bandsthrough and/or around the desired tissue, these needles may then be cutoff.

FIG. 37 shows a “Figure 8” device 3610 and a single band device 3652implanted around a sternum 3700. A full sternotomy cut line 3702 isdepicted by a dotted line running down the midline of sternum 3700.Depending on the particular procedure, a single device may be used toclose the sternum, or multiple devices may be used. A single type ofdevice among those shown in FIGS. 36A-36E may be used, or a combinationof different devices may be used.

FIGS. 38 and 39 show examples of the inventive closure devices beingused for partial sternotomies. In FIG. 38, a first type of partialsternotomy may be performed by making a first cut line 3800 along themid-line of the sternum 3700 as shown, but not extending the cut all theway through the cranial end of the sternum. A second cut 3802 may bemade from a left lateral extent of the sternum 3700 at a medial-cranialangle to the cranial end of the first cut 3800, as shown. A third cut3804 may be made from a right lateral extent of the sternum 3700 at amedial-cranial angle to the cranial end of the first cut 3800, as shown.The three cuts 3800, 3802 and 3804 do not necessarily need to be made inany particular order or direction. The left and right portions ofsternum 3700 may then be separated to access underlying tissue andorgans, such as during cardiac surgery.

To close the sternum after the above-described partial sternotomy, fourholes 3806 may be drilled through the portions of the sternum as shownin FIG. 38. A drill guide or template may be placed over sternum 3700 toaid the surgeon in locating proper positions for holes 3806. The distalends of bands 3618 of Figure 8 device 3610 (shown in FIG. 36A) may eachbe threaded through one of the lower holes 3806 in sternum 3700. Bands3618 may then each be threaded diagonally across the posterior side ofsternum 3700 and up through one of the upper holes 3806. To facilitatethis process, a curved needle may be attached or formed on the distalend of each band 3618, as will be subsequently described in more detail.Once the bands 3618 have been threaded through holes 3806, the needlesmay be cut off and bands 3618 may be threaded through buckles 3616.Bands 3618 may then be properly tensioned and excess lengths cut off,leaving the three portions of sternum 3700 properly secured for healingby device 3610 as shown in FIG. 38. It should be noted that view window3620 of device 3610 is positioned over the intersection of cut lines3800, 3802 and 3804.

FIG. 39 depicts a second type of partial sternotomy that may be closedwith a Figure Y device 3632. This second type of partial sternotomy maybe performed by making a first cut line 3900 along the mid-line of thesternum 3700 as shown, but not extending the cut all the way through thecranial end of the sternum. A second cut 3902 may be made from a right(or left) lateral extent of the sternum 3700 at a medial-caudal angle tothe cranial end of the first cut 3900, as shown. The two cuts 3900 and3902 do not necessarily need to be made in any particular order ordirection. The right portion of sternum 3700 (shown on the left in FIG.39) may then be separated from the remainder of the sternum to accessunderlying tissue and organs, such as during cardiac surgery.

To close the sternum after the above-described partial sternotomy, threeholes 3806 may be drilled through the portions of the sternum as shownin FIG. 39. A drill guide or template may be placed over sternum 3700 toaid the surgeon in locating proper positions for holes 3806. The distalends of bands 3638 of Figure Y device 3632 (shown in FIG. 36C) may eachbe threaded through one of the upper holes 3806 in sternum 3700. Bands3638 may then each be threaded across the posterior side of sternum 3700and up through the lowermost hole 3806. To facilitate this process, acurved needle may be attached or formed on the distal end of each band3638, as will be subsequently described in more detail. Once the bands3638 have been threaded through holes 3806, the needles may be cut offand bands 3638 may be threaded through the single buckle 3616. Bands3638 may then be properly tensioned and excess lengths cut off, leavingthe two portions of sternum 3700 properly secured for healing by device3632 as shown in FIG. 39. It should be noted that view window 3640 ofdevice 3632 is positioned over the intersection of cut lines 3900 and3902.

FIGS. 40-56 show additional closure device embodiments. Theseembodiments incorporate bands that may be pivoted relative to oneanother. Referring first to FIGS. 40-42, these embodiments can utilize amodular construction. FIG. 40 shows a portion of a single band 4000.Band 4000 includes a buckle 4002 at its proximal end, an enlargedmid-portion 4004 having a circular aperture 4006 therethrough, and anelongated distal end portion 4008. Band 4000 may be used as a closuredevice by itself, similar to device 3652 shown in FIG. 36E, or it may becoupled with other band(s), as will now be described.

FIG. 41 shows two bands 4000, one positioned over the other, with theircircular apertures 4006 aligned. Bands 4000 may be secured together attheir mid-portions 4004 by an eyelet 4100 placed through the aperture4006 of each band 4000. Eyelet 4100 keeps bands 4000 from separating,but allows them to pivot relative to one another about the center pointof their aligned apertures 4006. Details of an exemplary eyelet 4100 aresubsequently described relative to FIGS. 49A-49C. With bands 4000pivotably coupled together at their mid-portions, closure device 4102may be pivotably adjusted during installation to more closely adapt tothe particular anatomy of the patient it is being implanted in. Eyelet4100 may be fixed relative to the rotational position of one of thebands 4000, or both bands 4000 may pivot about eyelet 4100.

When implanted, two-band device 4102 may be secured around portions of asternum, as with the previously described devices. The distal endportion 4008 of each band 4000 may be fastened to the buckle 4002 on thesame band 4000 such that bands 4000 cross over each other on theposterior side of the sternum. Alternatively, the distal end portions4008 may be fastened to the buckles 4002 on the opposite band 4000 suchthat bands 4000 remain generally parallel to one another on theposterior side of the sternum.

FIG. 42 shows three bands 4000 pivotably coupled at their mid-portions4004 by eyelet 4100 to form closure device 4200. Like device 4102 shownin FIG. 41 and described above, device 4200 is pivotably adjustable andprovides three bands for securing multiple tissue portions, such asportions of a sternum after a sternotomy. Eyelet 4100 may be fixedrelative to the rotational position of one of the bands 4000, or allthree bands 4000 may pivot about eyelet 4100.

When implanted, three-band device 4200 may be secured around portions ofa sternum, as with the previously described devices. The distal endportion 4008 of each band 4000 may be fastened to the buckle 4002 on thesame band 4000 such all three bands 4000 cross over each other on theposterior side of the sternum. Alternatively, the distal end portions4008 of the outer pair of bands may be fastened to the buckles 4002 onthe opposite band 4000, and the center band may connect to itself, suchthat all three bands 4000 remain generally parallel to one another onthe posterior side of the sternum. Other fastening combinations may beused, such as the distal portion 4008 of each of the three bands 4000connecting to the buckle 4002 of a different band.

As shown in FIGS. 40-42 and described above, one, two or three bands4000 may be used as a tissue closure device, with the multiple bandembodiments of FIGS. 41 and 42 providing pivotable coupling betweenmid-portions 4004 of the bands 4000. In other embodiments (not shown),more than three bands 4000 may be pivotably coupled together in asimilar manner. Different devices, such as the single-band, double-band,and/or triple-band devices shown in FIGS. 40, 41 and 42, respectively,may be used together at different locations along a single sternum. Itshould be noted that a view window as previously described existsthrough the aperture(s) 4006 and/or eyelet 4100 in each of the exemplaryembodiments shown in FIGS. 40-42. In other embodiments, a view windowmay be omitted, such as by using a solid eyelet.

FIGS. 43 and 44 show perspective views of a double-band device 4300similar to device 4102 shown in FIG. 41. Device 4300 includes offsetfeatures 4302 on each of the bands 4000. Offset features 4302 have arectangular profile and may provide cutting and/or spring functionality,as previously described in relation to offset feature 3662 shown in FIG.36F. Offset features 4302 can also serve to limit pivoting movement.FIG. 43 shows bands 4000 pivoted such that offset features 4302 aremoved apart. FIG. 44 shows bands 4000 pivoted such that offset features4302 are moved into contact with one another. Further pivoting in thisdirection may be prevented by offset features 4302 contacting each otherand stopping one band 4000 from passing over the other.

FIGS. 45-48 show further embodiments of closure devices that utilize amodular construction. FIG. 45 shows an exploded view of two bandcomponents 4500 and 4502 that can be pivotably coupled together to formclosure device 4504. Band component 4500 has two end portions and amid-portion. A buckle 4002 is formed on one of the end portions. Theother end portion of band component 4500 is enlarged and has an aperture4006 therethrough. The mid-portion of band component 4500 is a slenderband. In other embodiments (not shown), the mid-portion of bandcomponent 4500 can be very short or non-existent, with buckle 4002directly coupled to the enlarged end portion of band component 4500.

Band component 4502 also has an enlarged end portion with an aperture4006 therethrough. Only part of the mid-portion of band component 4502of this embodiment is shown in the figures due to its long length. Themid-portion may extend to the opposite end portion (not shown) as a bandhaving a constant cross-section. A delivery needle may be attached orformed on the opposite end portion, as will be subsequently described indetail.

The right side of FIG. 45 shows the two bands 4500 and 4502, onepositioned over the other, with their circular apertures 4006 aligned.Bands 4500 and 4502 may be secured together at their end-portions by aneyelet 4100 placed through the aperture 4006 of each band. Eyelet 4100keeps bands 4500 and 4502 from separating, but allows them to pivotrelative to one another about the center point of their alignedapertures 4006. Details of an exemplary eyelet 4100 are subsequentlydescribed relative to FIGS. 49A-49C. With bands 4500 and 4502 pivotablycoupled together at their end-portions, closure device 4504 may bepivotably adjusted during installation to more closely adapt to theparticular anatomy of the patient it is being implanted in. Eyelet 4100may be fixed relative to the rotational position of one of the bands4500 or 4502, or both bands may pivot about eyelet 4100.

When implanted, modular closure device 4504 may be secured aroundportions of a sternum, as with the previously described devices, withthe distal end portion (not shown) of band 4502 fastened to the buckle4002 of band 4500.

FIG. 46 shows another exemplary modular closure device 4600. Device 4600is similar to device 4504 shown in FIG. 45, but includes an additionalband 4502. In other words, device 4600 is formed from one band 4500having a single buckle 4002, two bands 4502, and an eyelet 4100 passingthrough all three bands. In this embodiment, all three bands arepivotably coupled together at their end portions. Eyelet 4100 may befixed relative to the rotational position of one of the bands, or allthree bands may pivot about eyelet 4100. Buckle 4002 is configured toreceive the end portions (not shown) of both bands 4502.

FIGS. 47 and 48 show another exemplary modular closure device 4700.Device 4700 is similar to device 4600 shown in FIG. 46, but includes anadditional band 4500. In other words, device 4700 is formed from twobands 4500, each having a buckle 4002, two bands 4502, and an eyelet4100 passing through all four bands. In this embodiment, all four bandsare pivotably coupled together at their end portions. Eyelet 4100 may befixed relative to the rotational position of one of the bands, or allfour bands may pivot about eyelet 4100. Buckles 4002 are each configuredto receive an end portions (not shown) of one of the two bands 4502.

When implanted, device 4700 may be secured around portions of a sternum,as with the previously described devices. The distal end portion of eachband 4502 may be fastened to the buckle 4002 on the diagonally oppositeside of the device such that bands 4502 cross over each other on theposterior side of the sternum. Alternatively, the distal end portions ofbands 4502 may be fastened to the buckles 4002 on the same side of thedevice such that bands 4502 remain generally parallel to one another onthe posterior side of the sternum.

As shown in FIGS. 45-48 and described above, one, two, three or fourbands may be used as a tissue closure device, with the multiple bandembodiments providing pivotable coupling between end portions of thebands 4500 and 4502. In other embodiments (not shown), more than fourbands may be pivotably coupled together in a similar manner. Othercombinations may be formed by coupling some bands at their mid-portionsand other bands at their end portions to form a single device. Differentdevices, such as the double-band, triple-band and/or quadruple-banddevices shown in FIGS. 45, 46 and 47-48, respectively, and/or thedevices of FIGS. 40-44, may be used together at different locationsalong a single sternum. It should be noted that a view window aspreviously described exists through the apertures 4006 and eyelet 4100in each of the exemplary embodiments shown in FIGS. 45-48. In otherembodiments, a view window may be omitted, such as by using a solideyelet. Offset features such as those previously described may beincorporated into these embodiments.

FIGS. 49A-49C show various views of an exemplary eyelet 4100 that may beused with any of the tissue closure devices described herein. Duringassembly of the various devices, orbital riveting may be used to achievea minimal profile of eyelet 4100, so that it protrudes from the sternumor other tissue as little as possible. FIGS. 49A-49C show exemplaryeyelet 4100 before a lower flare is formed by orbital riveting. In someembodiments, eyelet 4100 is formed from 6 gage 316 stainless steeltubing having a wall thickness of 0.010 inches, and is given a hardtemper. Eyelet 4100 may have a nominal outer diameter of 0.203 inches,and an outer flare diameter of 0.301 inches.

In some embodiments of the modular devices described above, the bandsare formed from 316L stainless steel, have a width of about 0.138 inchesand a thickness of about 0.012 inches. In some embodiments, the overalllength of bands 4000 and 4502 is about 10 to 14 inches and the overalllength of bands 4500 is about 1.2 inches. In some embodiments, theenlarged mid-portions and end portions of the bands have an outerdiameter of about 0.5 inches, with an aperture 4006 therethrough havingan inside diameter of 0.252 inches. In some embodiments, the center ofbuckle 4002 is placed about 0.860 inches from the center of aperture4006.

FIG. 50A shows another embodiment of a tissue closure device. Device5000 may be formed from a first band 5002 and a second band 5004. Abuckle 4002 may be located at one end of each band 5002 and 5004. Inthis embodiment, band 5002 includes an offset mid-portion 5006, and band5004 includes an offset mid-portion 5008. Each offset portion isprovided with a circular aperture 4006. To fabricate device 5000, theoffset portions 5006 and 5008 may be placed over one another such thatthe apertures 4006 align. An eyelet 4100, such as previously described,may then be inserted through apertures 4006 and secured in place byorbital riveting. This arrangement creates an H-shaped device 5000 asshown, with bands 5002 and 5004 pivotably coupled to one another attheir mid-portions. Bands 5002 and 5004 are able to pivot relative toone another and/or eyelet 4100 about the common center point ofapertures 4006 in this embodiment. In use, the distal end portion ofeach band may encircle tissue such as portions of a sternum and bereceived in the buckle 4002 located at the opposite end of the band.

FIG. 50B shows an alternative embodiment of device 5000. In thisembodiment, the aperture 4006′ in at least one of the offset portions5006 and 5008 is elongated rather than circular. This allows eyelet 4100to slide with respect to the elongated aperture 4006′, thereby allowingthe width W (shown in FIG. 50A) between bands 5002 and 5004′ to beadjusted prior to or during installation.

FIG. 50C shows another alternative embodiment of device 5000. In thisembodiment, buckles 4002 are located for installation on opposite sidesof a sternum. This arrangement allows the closure device to befabricated from two identical bands 5004, rather than from twosymmetrically opposite bands 5002 and 5004 as shown in FIG. 50A.

FIGS. 51-54 show additional features that may be incorporated into anyof the closure devices disclosed herein. In some embodiments, theenlarged portion 5100 of band 5102 may be provided with protrudingfeatures such as teeth 5104. As shown in FIG. 52, teeth 5104 may beprovided on the underside of enlarged portion 5100 around aperture 4006.Protruding teeth 5104 can help lock band 5102 in position on both halvesof sternum 5300, as shown in FIG. 53, when band 5102 is tightened inplace. Teeth 5104 can also help lock band 5102 in place against anotherband, as depicted in FIG. 54, when the two bands are tightened.

The top side of band 5102 may also be provided with protruding features(not shown), and/or mating recesses 5106 (shown in FIG. 51) aroundaperture 4006 for receiving the protruding features of an adjoining band5102. In this embodiment, mating recesses 5106 on the top side of band5102 are formed in the same punching process that produces the teeth5104 on the underside of band 5102. As can be appreciated from theoverlapping bands 5102 depicted in FIG. 54, teeth on the underside ofthe top band 5102 can engage with recesses in the top side of the bottomband 5102 to rotationally lock the two bands together upon tightening.

Other protruding and recessed features and orientations may be used insimilar embodiments. For example, teeth 5104 may be oriented radiallyinstead of tangentially around aperture 4006. These arrangements may beused with or without an eyelet 4100 (FIGS. 49A-49C) through apertures4006.

Another feature depicted in FIGS. 51, 53 and 54 is a bend 5108 that maybe located in band 5102 adjacent to buckle 4002. This feature may beincorporated into any of the closure devices disclosed herein. Bend 5108can aid in the positioning of band 5102 on the anterior surfaces ofsternum 5300 with buckle 4002 positioned on a lateral surface of thesternum, as shown in FIGS. 53 and 54. Bend 5108 can also serve to betteralign buckle 4002 for receiving the distal end of band 5102 after itencircles the sternum 5300. In some embodiments, band 5102 may be easilybent by hand in the operating room. However, pre-bending band 5102during manufacture can aid the surgeon as described above. In someembodiments, band 5102 is bent about 45 degrees at bend 5108. In otherembodiments, band 5102 is bent about 60 degrees at bend 5108.

FIG. 55 shows another feature that may be incorporated into any of theclosure devices disclosed herein. Band 5500 is shown with at least aportion 5502 of its top surface having a texture applied. Such a surfacemay be created by knurling, dimpling, etching, or other well knownprocesses. Surface portion 5502 may be provided with a coating having ahigh coefficient of friction. Such texturing and/or coating may belocated on both the top and bottom surfaces of a band, and/or onmultiple bands. Surface portion 5502 can provide a grip interfacebetween mating bands and/or the underlying tissue to inhibit movementafter the band(s) have been implanted.

FIG. 56 shows another exemplary tissue closure device 5600. Device 5600may be formed by pivotably coupling two bands 5602 and 5604 at amid-portion of each band, in a similar manner to the previouslydescribed modular devices. When assembled, device 5600 forms an H-shapeddevice similar to device 5000 shown in FIG. 50A.

FIGS. 57A and 57B shows another exemplary tissue closure device 5700.Device 5700 may be formed from an upper component 5702 and a lowercomponent 5704 that are pivotably coupled to one another. Bands 5706extend from lower component 5704. Locking mechanisms 5708 may be formeddirectly in upper component 5702. After wrapping around a portion of asternum or other tissue, the distal ends of bands 5706 may be receivedthrough locking mechanisms 5708. Pivoting adjustment between uppercomponent 5702 and lower component 5704 may allow device 5700 to betteradapt to the tissue it is securing.

FIGS. 58-66 show various alternatives for forming buckles and otherlocking mechanisms, and for securing bands of tissue closure deviceswith the locking mechanisms. Referring first to FIGS. 58A-58C, anexemplary method for forming buckle 3616 on strap 3614 will bedescribed. FIG. 58A shows a plan view of the distal end of strap 3614that has been punched out of sheet material with a T-shaped pattern forforming buckle 3616. Interlocking features 5800 and 5802 may be providedon opposing ends of the T-shaped pattern. The distal end of strap 3614forms the bottom of buckle 3616. The pattern may be first bent along twobend lines 5804 to form two vertically extending side walls. The patternmay then be bent along two other bend lines 5806 such that the ends ofthe T-shaped pattern come together and form the top of buckle 3616. Theinterlocking features 5800 and 5802 engage each other as shown in FIG.58B to keep buckle 3616 from coming apart when securing a band. In someembodiments, Interlocking features 5800 and 5802 may be welded together.In other embodiments, such as shown in FIG. 61A, the interlockingfeatures may be omitted. Depending on the loading configuration of thebuckle, the straight butt joint may be welded or left unwelded. Buckle3616 may be configured to receive one, two, or more bands therethrough.

FIGS. 59A-59D show one embodiment for securing band 3618 in buckle 3616.FIG. 59A shows one of the bands 3618 of device 3610 inserted into one ofthe buckles 3616. During installation on a sternum or other tissue, asurgeon may temporarily secure a band 3618 in place by bending the bandupward, as shown in FIG. 58B. The surgeon may then straighten the band,readjust it, and secure it again by re-bending the band 3818. Atensioning tool, as previous described, may be used to place a variableor predetermined tension on band 3618 relative to buckle 3616 and placea bend in band 3618 to secure it. The same tool, or a different tool,may be used to shear off excess band 3618. The cutting tool may shearband 3618 in a predetermined location, such as adjacent to the top ofbuckle 3616, as shown in FIGS. 59C and 59D. In this manner, an L-shapedend 5900 is left on the distal end of tensioned band 3618 to prevent thedistal end of band 3618 from being pulled back through buckle 3616.

FIGS. 60A-60B show another embodiment for securing band 3618 in buckle3616. As shown, the distal end of band 3618 may be formed into aU-shaped portion 6000 that wraps around the top of buckle 3616. Such anarrangement can help an unwelded buckle 3616 remain intact under load.This securing method may be accomplished manually, or specializedtensioning, bending and cutting tool(s) can be configured to performthese operations more quickly and consistently.

FIGS. 61A-61B show another embodiment for securing band 3618 in buckle3616. As shown, a lance 6100 may be formed on the distal end of band3618. Lance 6100 may have a flat surface 6102 that abuts against the topof buckle 3616. Such an arrangement can withstand very high shear forcesthat may be applied to it. Lance 6100 may be formed by a tool similar tothose previously described.

FIGS. 62A-62B show another embodiment for securing band 3618 in buckle3616. As shown, a dimple 6200 may be formed on the distal end of band3618. Dimple 6200 may be formed by a tool similar to those previouslydescribed.

FIG. 63 shows another embodiment for securing band 3618 in buckle 3616.As shown, a U-shaped crease 6300 may be formed on the distal end of band3618. Crease 6300 may be formed by a tool similar to those previouslydescribed.

FIGS. 64A-64D show another embodiment for securing band 3618 in abuckle. As shown, a slidable shim 6400 may be located within buckle6402. Shim 6400 can slide in a direction that allows band 3618 to befurther inserted into buckle 6402, but engages in a wedge-like mannerbetween the top of band 3618 and the top of buckle 6402 to prevent band3618 from being withdrawn in an opposite direction. Tabs 6404 may beprovided on one or both sides of shim 6400. These tabs 6404 may extendinto windows 6406 formed in the side walls of buckle 6402. Thisarrangement serves to slidably captivate shim 6400 in buckle 6402, andallows a user to slide shim 6400 relative to buckle 6402 to release band3618. A wave washer 6408 may be provided between the top of shim 6400and the top of buckle 6402, as shown in FIG. 64D.

FIGS. 65A-65H show another embodiment for securing band 3618 in abuckle. As shown, a slidable wedge 6500 may be located within buckle6502. Wedge 6500 can slide in a direction that allows band 3618 to befurther inserted into buckle 6502, but engages between the bottom ofband 3618 and the bottom of buckle 6502 to prevent band 3618 from beingwithdrawn in an opposite direction.

FIGS. 66A-66C show another embodiment for securing band 3618 in abuckle. As shown, a ball 6600 may be located within buckle 6602. Ball6600 can slide or roll in a direction that allows band 3618 to befurther inserted into buckle 6602, but engages in a wedge-like mannerbetween the top of band 3618 and the top of buckle 6602 to prevent band3618 from being withdrawn in an opposite direction.

FIGS. 67-76 show further details of needle configurations that may beused with any of the tissue closure devices disclosed herein.

It should be understood from the foregoing that, while particularimplementations have been illustrated and described, variousmodifications can be made thereto and are contemplated herein. It isalso not intended that the invention be limited by the specific examplesprovided within the specification. While the invention has beendescribed with reference to the aforementioned specification, thedescriptions and illustrations of the preferable embodiments herein arenot meant to be construed in a limiting sense. Furthermore, it shall beunderstood that all aspects of the invention are not limited to thespecific depictions, configurations or relative proportions set forthherein which depend upon a variety of conditions and variables. Variousmodifications in form and detail of the embodiments of the inventionwill be apparent to a person skilled in the art. It is thereforecontemplated that the invention shall also cover any such modifications,variations and equivalents.

What is claimed is:
 1. A method for connecting two tissues, comprising:providing a connection device including: a first band and a second band;and a first buckle coupled to the first band and a second buckle coupledto the second band; wherein the first band is formed of biocompatiblematerial having at least two end portions and a mid-portiontherebetween, the first band having a top and bottom surface; the secondband formed of biocompatible material having at least two end portionsand a mid-portion therebetween, the second band having a top and bottomsurface; and wherein the first and second bands each have a thicknessbetween the top and bottom surfaces, and a width that is greater thanthe thickness, wherein the top or bottom surface of the first bandoverlies the top or bottom surface of the second band to define a commonplane in an overlap region and are pivotably coupled together in theoverlap region to pivot relative to one another about an axis that isperpendicular to the common plane, wrapping the first band around thetwo tissues and connecting the first band to the first buckle; andwrapping the second band around the two tissues and connecting thesecond band to the second buckle.
 2. The method of claim 1 wherein thetwo tissues are bone tissue.
 3. The method of claim 2 wherein the twotissues form a part of a sternum.
 4. The method of claim 1 wherein thefirst band and the second band cross one another.
 5. The method of claim1, further comprising a first delivery needle connected to an endportion of the first band and a second delivery needle connected to anend portion of the second band; further comprising penetrating a portionof one of the two tissues with the first delivery needle and seconddelivery needle.
 6. A method for connecting two tissues, comprising:providing a connection device including: a central body; a first bandand a second band, both bands extending from the central body; and atleast one buckle coupled to the central body; wrapping the first bandaround the two tissues and connecting the first band to the at least onebuckle; and wrapping the second band around the two tissues andconnecting the second band to either the at least one buckle or to asecond buckle coupled to the central body, wherein the first band isformed of biocompatible material having at least two end portions and amid-portion therebetween, the first band having a top and bottomsurface; the second band formed of biocompatible material having atleast two end portions and a mid-portion therebetween, the second bandhaving a top and bottom surface; and a delivery needle connected to oneof the end portions of each of the bands, wherein the first and secondbands each have a thickness between the top and bottom surfaces, and awidth that is greater than the thickness, wherein the top or bottomsurface of the first band overlies the top or bottom surface of thesecond band to define a common plane in an overlap region and arepivotably coupled together in the overlap region to pivot relative toone another about an axis that is perpendicular to the common plane. 7.The method of claim 6, wherein the first and second bands are pivotablycoupled at the mid-portion of at least one of the bands.
 8. The methodof claim 6, wherein the first and second bands are pivotably coupled atthe mid-portion of both of the bands.
 9. The method of claim 6, furthercomprising a third band having at least two end portions and amid-portion therebetween, wherein the first, second and third bands arepivotably coupled together.
 10. The method of claim 6, wherein the firstand second bands are pivotably coupled together by an eyelet that formsa view window through the bands.
 11. The method of claim 6, wherein eachof the first and second bands comprises an offset portion, each of theoffset portions being configured to receive an eyelet therethrough. 12.The method of claim 6, wherein the first and second bands are pivotablycoupled at a pivoting portion of each band, wherein at least one of thepivoting portions comprises at least one protrusion extending toward anopposite pivoting portion to inhibit pivoting of the bands after thedevice is implanted.
 13. A method for connecting two tissues,comprising: providing a connection device including: a first band formedof biocompatible material having at least two end portions and amid-portion therebetween, the first band having a top and bottomsurface; and a second band formed of biocompatible material having atleast two end portions and a mid-portion therebetween, the second bandhaving a top and bottom surface; wherein the first and second bands eachhave a thickness between the top and bottom surfaces, and a width thatis greater than the thickness, wherein the top or bottom surface of thefirst band overlies the top or bottom surface of the second band todefine a common plane in an overlap region and are pivotably coupledtogether in the overlap region to pivot relative to one another about anaxis that is perpendicular to the common plane; and wherein the firstand second bands are pivotably coupled together by an eyelet that formsa view window through the first and second bands, wrapping the firstband around the two tissues and connecting the first band to a firstbuckle; and wrapping the second band around the two tissues andconnecting the second band to a second buckle.
 14. The method of claim13, wherein the first and second bands are pivotably coupled at themid-portion of at least one of the bands.
 15. The method of claim 13,wherein the first and second bands are pivotably coupled at themid-portion of both of the bands.
 16. The method of claim 13, furthercomprising a third band having at least two end portions and amid-portion therebetween, wherein the first, second and third bands arepivotably coupled together.
 17. The method of claim 13, wherein thefirst and second bands are pivotably coupled at a pivoting portion ofeach band, wherein at least one of the pivoting portions comprises atleast one protrusion extending toward an opposite pivoting portion toinhibit pivoting of the bands after the device is implanted.